Careers

Adagio is always looking for highly qualified people who share our mission of improving the quality of people’s lives. Join a highly motivated team focused on transforming how all forms of cardiac arrhythmias are being treated.

Explore the current career opportunities below. For more information, contact: careers@adagiomedical.com

Open Positions

Apply

JOB TITLE:  Sr. Embedded GUI Application Software Engineer

DEPARTMENT:  Research and Development (Console)

REPORTS TO:  Engineering Manager

JOB SUMMARY

The Sr. Embedded GUI Application Software Engineer position at Adagio Medical is an engineering professional with at least 5+ years of experience developing software for GUI and/or embedded application. The qualified candidate will be responsible for developing an end to end GUI application for the next generation of Adagio’s consoles with minimum supervision form the engineering management team. This engineer participates in other areas of software programming like (but not limited to) embedded application development, unit testing and code reviews of other team members. This position also requires the candidate to participate in all stages of SDLC as writing requirements, test protocols, software architecture and executing the test plans in an agile environment.

DUTIES AND RESPONSIBILITIES

  • Design and implement software of embedded devices and systems from requirements to production and commercial deployment. Functionality includes GUI, controlling software, algorithms, and integration with subsystems.
  • Participate in all phases of the software life-cycle, including concept, requirements, design, implementation, testing, and maintenance.
  • Knowledge and understanding of OOD and OO methodology, full SDLC processes and software unit testing
  • Ensure regulatory compliance of the development process and the commercialized product.
  • Collaborate with multidisciplinary team members including system, electrical, mechanical, clinical, marketing, quality, technical services, and manufacturing.
  • Proficiency in multiple programming languages including C++ and Qt Quick/QML, version control systems, operating systems including Windows and Linux.
  • Proficiency in programming embedded hardware processors like STM32 and iMX6/8.
  • Proficiency in developing GUI application using Qt toolkit (QML) and Yocto Project.
  • Strong documentation and writing skills
  • Adequate knowledge of reading schematics and understanding of communication protocols like UART and USB.
  • Supervise other junior engineers in the team as needed.

REPORTING

This position will report to the Engineering Manager. Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in software or electrical engineering or equivalent experience.
  • Minimum – Five (5) years of experience developing GUI applications using C++ and QML.
  • Minimum – Five (5) years of experience developing OOP applications, full SDLC processes and software unit testing.
  • Minimum – Fine (5) years of experience in embedded systems design with preemptive, multitasking real-time operating systems.
  • Desirable – Knowledge of Yocto Project and Boot to Qt applications development for iMX6/8 processor.
  • Desirable – Three (3) years industry experience with a medical device/pharmaceutical/biotechnology company and familiar with IEC 62304 standard.
Apply

JOB TITLE: Clinical Research Specialist

DEPARTMENT:  Clinical Affairs

REPORTS TO:  Clinical Trial Manager

Position Summary

The primary role of the Clinical Research Specialist (CRS) is to provide expertise for managing and meeting the objectives of a clinical study.  This includes supporting the development and implementation of a Clinical Investigational Plan (CIP) and appropriate training to all participants of the assigned study for the conduct of clinical research in compliance with applicable regulatory standards, Internal Review Board/Ethics Committees IRB/EC policies and procedures and Adagio Medical internal requirements.  The CRS is expected to provide any cross-functional support needed for departments within Adagio Medical in an effort to achieve desired corporate goals.

Duties and Responsibilities:

  • Assist in preparing study objectives, scope, and schedule of all assigned clinical studies in order to meet corporate objectives
  • Assist in the development of all aspects of a CIP and supporting documents (protocol, informed consent, CRFs, clinical trial agreement, etc.) in consultation with cross-functional departments within Adagio Medical
  • Support and prepare documentation for clinical study submissions and approvals (domestic and international)
  • Maintain clinical files, EDC updates, EDC monitoring, and patient data analysis
  • Support the adverse event reporting and adjudication process for all assigned studies including assistance with the conduct of all independent adjudication committee meetings
  • Support the shipping and receiving of all investigational product required for a study.
  • Report on progress of all assigned studies as requested
  • Support customer complaints and product returns for all assigned studies
  • Communicate and coordinate directly with all CROs, Investigators and coordinators for assigned studies to support clinical activities
  • Ensure compliance with regulatory directives, GCP, policy and procedure, and the CIP
  • Provide cross-function support to other departments within Adagio Medical

Reporting:

This position will report to a Clinical Trial Manager within the department of Clinical Affairs.  Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans.  Duties may change to support revisions to corporate goals and immediate needs.

Job Qualification Requirements:

  • Minimum – Bachelor’s Degree in a life science, medical professional, or biomedical engineering field of study
  • Minimum – two (2) years industry experience with a medical device/pharmaceutical/biotechnology company
  • Minimum – two (2) years experience working directly with physicians and health care professionals
  • Minimum – Demonstration of excellent communication (written and oral) skills
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Certification from an accredited GCP training program and a HIPAA compliance program
  • Desirable – Certification as a CRA by the Association of Clinical Research Professionals (ACRP) or CRP by the Society of Clinical Research Associates (SOCRA)
Apply

JOB TITLE:  Regulatory Specialist

DEPARTMENT:  Regulatory

REPORTS TO:  VP RA/QA

JOB SUMMARY

The primary responsibility of the regulatory specialist is to perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance.  The position requires a high level of innovative thought and problem-solving skills.  Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success.   In addition to the above responsibilities, the regulatory specialist is required to interact with multiple departments within the Adagio Medical organization as well as regulatory bodies.

DUTIES AND RESPONSIBILITIES

  • Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities)
  • IDE, PMA, 510(k), Design Dossiers, Technical Files.
  • Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.
  • Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
  • Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.
  • Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.

REPORTING

This position will report directly to the VP, Quality and Regulatory Affairs.  Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.

JOB QUALIFICATION REQUIREMENTS

  • Bachelor’s degree (B.S.) from four-year College or University
  • Three (3) years minimum experience in regulatory affairs.
  • Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to company products.
  • Knowledge and understanding of Quality and Regulatory concepts and application
  • Strong analytical, planning and organizational skills
  • Strong interpersonal and communications skills (oral & written)
  • Self-starter with ability to work independently under pressure and react quickly to changing priorities
  • Proficient in MS Office products.
Apply

JOB TITLE: Clinical Safety Specialist

DEPARTMENT:       Clinical Affairs

REPORTS TO:         VP, Clinical Affairs

Position Summary

The Clinical Safety Specialist supports clinical study adverse event data collection, assessment, adjudication and analysis.  This position also supports internal and external review of safety data by preparing data summaries and presentations. Responsibilities may include safety reporting for commercial products.

Duties and Responsibilities:

  • Process, review, evaluate, and track incoming adverse events for assigned studies
  • Work collaboratively with Regulatory Affairs, Clinical Affairs and clinical study site research personnel to ensure timely reporting of AEs, SAEs and UADE’s, in accordance with applicable regulations and company procedures
  • Maintain safety database for assigned studies
  • Support additional safety-related tasks as directed
  • Ensure consistency and regulatory compliance in adverse event definitions, adjudications, coding and reporting across studies as appropriate for the specified protocols
  • Provide internal support (e.g. document review, report preparation, slide generation) for management reviews
  • Provide preparation and support for external safety related committees such as a CEC and DSMB
  • Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices
  • Assist with writing the safety section of clinical protocols

Reporting:

This position will report to the VP, Clinical Affairs within the department of Clinical Affairs.  Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans.  Duties may change to support revisions to corporate goals and immediate needs and may include safety reporting for commercial devices.

Job Qualification Requirements:

  • Bachelor’s degree or equivalent experience
  • 3-4 years of clinical safety responsibilities for Class II and/or III medical devices (preferred) in clinical trial or commercial environments
  • Experience communicating directly with healthcare professionals in support of safety related data collection
  • Working knowledge of pharmaceutical, biotechnology and/or medical device clinical trial data management processes and regulatory requirements
  • Experience in a cardiovascular therapeutic field (preferred)
  • Familiarity with EDC systems
  • Knowledge and working familiarity with safety management systems
  • Working knowledge of medical terminology, acronyms, and ability to communicate effectively with medical personnel
  • Strong Microsoft Office skills, including Excel, Word, and Power Point
Apply

JOB TITLE: Clinical Data Associate

DEPARTMENT: Clinical Affairs

REPORTS TO: Director, Clinical Affairs

POSITION SUMMARY

The primary role of the Data Management Associate (DMA) is to provide expertise for managing data and meeting the objectives of a clinical study. This includes supporting the development and implementation of a Data Management Plan (DMP) and assistance with implementing the process for data collection utilizing an electronic data capture system. Training of all internal and site research personnel will be a requirement throughout the conduct of the study. All support for data management will be in compliance with applicable regulatory standards, Internal Review Board/Ethics Committees IRB/EC policies and procedures and Adagio Medical internal requirements. The DMA is expected to provide any cross-functional support needed for departments within Adagio Medical in an effort to achieve desired corporate goals.

DUTIES AND RESPONSIBILITIES

  • Complete data management activities to meet project timelines from study start up to database lock.
  • Data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting.
  • Assists with data management start up activities, database cleaning and lock activities including review and development of case report forms, data management plans, and database development.
  • Reviews and processes clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
  • Assist with identifying data trends and/or issues.
  • Work closely with Clinical Affairs project team members to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
  • Assist completing requests when working with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
  • Participate in cross functional team meetings as requested
  • Manage multiple and varied tasks, prioritize workload with attention to detail.
  • Other duties as assigned.

REPORTING

This position will report directly to the Director, Clinical Affairs. Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans. Duties may change to support revisions to corporate goals and immediate needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in a related field or High School equivalent with at least 6+ years experience working in a clinical research data handling environment with relevant practical medical device experience
  • Minimum – two (2) years industry experience in data management with a medical device/pharmaceutical/biotechnology company
  • Minimum – one (1) year experience supporting the day-to-day data management activities of a clinical study with an EDC system
  • Minimum – Work experience demonstration of attention to detail while maintaining work efficiency, and ability to prioritize activities across various assigned study tasks.
  • Minimum – Work experience demonstration of data listing review and query management
  • Minimum – Knowledge and use of Microsoft applications
  • Desirable – Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, FDA guidelines, and GCDMP.
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Prior experience with Medrio, Medidata, IBM, or other similar electronic database systems.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Apply

JOB TITLE: Clinical Trial Manager

DEPARTMENT: Clinical Affairs

REPORTS TO: Vice President, Clinical Affairs

Position Summary

The primary responsibility of the Clinical Trial Manager is to manage assigned clinical studies. Included in these tasks are responsibilities that can be outsourced or completed within the department. Primary tasks would involve but not be limited to: Documentation generation, data collection oversight, conducting site visits for initiation, site monitoring and closeout, maintaining device accountability, maintaining study records and communicating with appropriate site staff for the successful completion of Adagio Medical clinical studies.  As a key team leadership member, close interaction will be necessary with all departments and duties may include activities outside of the job description, dependent on needs of Adagio Medical

The position requires a high level of innovative thought and problem-solving skills.  Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success.   In addition to the above responsibilities, the Clinical Trial Manager is required to interact with multiple departments within the Adagio Medical organization as well as investigators, site coordinators, IRB chairpersons, hospital staff and regulatory bodies.  Domestic and international travel may be sporadic in nature and usually confined to study start-up and closeout activities.  Overall, it should be limited to less than ten percent of the time.

Duties and Responsibilities:

  • Participate in drafting protocols, CRFs, and all procedure documents (CMP, SMP, DMP, etc) to support clinical studies
  • Supervise the conduct of clinical trials (both US and international). Studies may include both pre market and post market studies
  • Perform, oversee and work closely with clinical department members and contracted staff to completely and accurately comply with GCP guidelines in the collection of study data
  • Perform, oversee and work closely with clinical department members and contracted staff to review, clarify and obtain data changes (via DCRs) with site personnel. Assist in reviewing data listings and query generation
  • Perform, oversee and work closely with clinical department members and contracted staff to complete site visits for initiation, follow-up, or closure of a study such that an adequate GCP report may be filed at the completion
  • Work closely and communicate regularly with field personnel on the status of the ongoing trials.
  • Ensure that all company personnel and representatives are trained to protocols and proper study conduct using Good Clinical Practices
  • Perform, oversee and work closely with clinical department members and contracted staff to maintain device accountability records. Coordinate outgoing study supplies including study devices\
  • Provide feedback to management on the ongoing progress of assigned trials and study related activities.
  • Assist with the development and implementation of necessary operating procedures for department success
  • Assist with all Adagio Medical regulatory submissions
  • Recognize trends and study difficulties that may impact outcomes. Problem solve and define a solution matrix for management discussion

Reporting:

This position will report directly to the VP, Clinical Affairs. Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.

Job Qualification Requirements:

  • Minimum – Bachelor’s Degree in a life science, medical professional, or biomedical engineering field of study
  • Minimum – Five (5) years industry experience with a medical device/pharmaceutical/biotechnology company (preferably cardiology)
  • Minimum – Two (2) years experience working directly with physicians and health care professionals
  • Minimum – Knowledge of electronic data capture systems
  • Minimum – Demonstration of excellent communication (written and oral) skills
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Prior experience with an IDE study supporting a PMA
  • Desirable – Ability to present/teach detailed technical and clinical information, to all levels of company personnel and customers.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
  • Desirable – Certification as a CRA by the Association of Research Professionals (ACRP) The Society of Clinical Research professionals (SCRA)
Apply

JOB TITLE:  Principal Engineer

DEPARTMENT:  Research and Development (Catheters)

REPORTS TO:  Director of Engineering

JOB SUMMARY

The principal engineering position at Adagio Medical is an engineering professional with 10+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for providing guidance and oversight to multiple teams or individuals working on numerous products or developing various forms of medical device technologies. This individual is a leader who thinks strategically and has long-range company goals in mind and will manage all phases of technical projects. They will oversee the product’s or project’s conception, product design, product design documentation and manage scheduling, estimating and securing materials and vendors. The Principal engineer will also conduct engineering studies and investigations and prepare reports for company leadership. They also provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.

DUTIES AND RESPONSIBILITIES

  • Provide technical leadership for the design and development of medical devices
  • Assist in the transfer of new products from R&D to production
  • Establish processes and manufacturing documentation for new catheter products
  • Identify processes to fabricate new products
  • Use CAD software (Solidworks preferred) for part and assembly design and detail drawings
  • Perform experiments to determine validity of designs
  • Provide technical leadership for development projects
  • Define product requirements
  • Design and development of tooling
  • Perform or manage design verification, equipment qualification and product and process validations
  • Prepare and maintain product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
  • Supervise and advise team members as necessary
  • Comply with applicable FDA and international regulatory laws/standards
  • Other duties as assigned or required

REPORTING

This position will report directly to the Director of Engineering.  Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience.
  • Minimum – Ten (10) years industry experience with a medical device/pharmaceutical/biotechnology company
  • Minimum – Two (2) years supervisory experience
  • Minimum – Knowledge FDA/MDD regulations as they relate to Class III medical devices.
  • Minimum – Demonstration of excellent communication (written and oral) skills
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – Prior experience with non-invasive medical devices (catheters).
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Ability to present/teach detailed technical information, to all levels of company personnel and customers.
Apply

JOB TITLE: Field Clinical Engineer

DEPARTMENT: Clinical Affairs

REPORTS TO: Director, Clinical Affairs

JOB SUMMARY

The primary responsibility of the Field Clinical Engineer is to manage assigned clinical sites during study start-up activities, study recruitment and treatment, and follow-up study phases of global clinical research, as assigned. Primary tasks would involve but not be limited to: The overall management of all aspects of the site regulatory process, clinical education and case coverage, data collection oversight, conducting site visits for initiation, site monitoring and closeout, maintaining device accountability, maintaining study records and communicating with appropriate site staff and investigators for the successful completion of Adagio Medical clinical studies. As the primary contact for all assigned sites, responsibilities will include the communication of related clinical information to departmental members plus the key personnel within Adagio Medical essential to R and D advancement. These tasks and responsibilities may be outsourced or completed within the department dependent on company needs. Additional duties may include activities outside of the job description, dependent on needs of Adagio Medical Inc.

The position requires a high level of innovative thought and problem-solving skills. Tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the Field Clinical Engineer is required to interact with multiple departments within the organization as well as investigators, site coordinators, IRB chairpersons, hospital staff and regulatory bodies. Domestic travel is a requirement and may be sporadic in nature. Occasional international travel may be required for training purposes and procedure coverage. Overall, it should be limited to less than sixty percent of the time.

DUTIES AND RESPONSIBILITIES

  • Participate in all aspects of the conduct of clinical trials (primarily US). Studies may include both pre market and post market studies.
  • Educate and train all assigned site participants on the proper use of Adagio Medical products thus insuring safe, efficacious use of Adagio Medical products.
  • Must be able to communicate current and relevant cardiac electrophysiology data, and trends as they relate to the appropriate use of Adagio Medical equipment and the treatment of our targeted study population.
  • Oversee assigned clinical cases including the catheter and console use, data collection and adherence to protocol.
  • Perform, oversee and work closely with in house or contracted staff to completely and accurately comply with GCP guidelines in the collection of study data.
  • Perform, oversee and work closely with in house or contracted staff to review, clarify and obtain data clarification (via DCRs) with site personnel. Assist in reviewing data listings and query generation.
  • Perform, oversee and work closely with in house or contracted staff to complete site visits for qualification, initiation, follow-up, or closure of a study such that an adequate GCP report may be filed at the completion.
  • Work closely and communicate regularly with departmental personnel on the status of assigned sites for all clinical trials.
  • Perform, oversee and work closely with in house or contracted staff to maintain device accountability records. Coordinate outgoing study supplies including study devices.
  • Provide feedback to management on the ongoing progress of assigned trials and study related activities.
  • Assist with the development and implementation of necessary operating procedures for department success.
  • Assist with all Adagio Medical regulatory submissions, as assigned.
  • Recognize and report trends and study difficulties that may impact outcomes. Participate in problem solving that defines a solution matrix for management discussion.

REPORTING

This position will report directly to the Director, Clinical Affairs. Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans. Duties may change to support revisions to corporate goals and immediate needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – B.S. in Life/Health Sciences, Nursing, or Engineering
  • Minimum – 5 to10 years industry experience in a medical device company (preferably Cardiology).
  • Minimum – 4 years experience working directly with physicians and healthcare professionals.
  • Desirable – Ability to present/teach detailed technical and clinical information, to all levels of company personnel and customers.
  • Desirable – Excellent communication, presentation, analytical, interpersonal and problem-solving skills. Powerpoint, MS Project, and EXCEL skills a plus.
  • Desirable – Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
  • Desirable – Experience in IDE clinical studies and working with an early start up company a plus.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Apply

JOB TITLE: Field Clinical Engineer

DEPARTMENT: Clinical Affairs Save

REPORTS TO: Director, Clinical Affairs

JOB SUMMARY

The primary responsibility of the Field Clinical Engineer is to manage assigned clinical sites during study start-up activities, study recruitment and treatment, and follow-up study phases of global clinical research, as assigned. Primary tasks would involve but not be limited to: The overall management of all aspects of the site regulatory process, clinical education and case coverage, data collection oversight, conducting site visits for initiation, site monitoring and closeout, maintaining device accountability, maintaining study records and communicating with appropriate site staff and investigators for the successful completion of Adagio Medical clinical studies. As the primary contact for all assigned sites, responsibilities will include the communication of related clinical information to departmental members plus the key personnel within Adagio Medical essential to R and D advancement. These tasks and responsibilities may be outsourced or completed within the department dependent on company needs. Additional duties may include activities outside of the job description, dependent on needs of Adagio Medical Inc.

The position requires a high level of innovative thought and problem-solving skills. Tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the Field Clinical Engineer is required to interact with multiple departments within the organization as well as investigators, site coordinators, IRB chairpersons, hospital staff and regulatory bodies. Domestic travel is a requirement and may be sporadic in nature. Occasional international travel may be required for training purposes and procedure coverage. Overall, it should be limited to less than sixty percent of the time.

DUTIES AND RESPONSIBILITIES

  • Participate in all aspects of the conduct of clinical trials (primarily US). Studies may include both pre market and post market studies.
  • Educate and train all assigned site participants on the proper use of Adagio Medical products thus insuring safe, efficacious use of Adagio Medical products.
  • Must be able to communicate current and relevant cardiac electrophysiology data, and trends as they relate to the appropriate use of Adagio Medical equipment and the treatment of our targeted study population.
  • Oversee assigned clinical cases including the catheter and console use, data collection and adherence to protocol.
  • Perform, oversee and work closely with in house or contracted staff to completely and accurately comply with GCP guidelines in the collection of study data.
  • Perform, oversee and work closely with in house or contracted staff to review, clarify and obtain data clarification (via DCRs) with site personnel. Assist in reviewing data listings and query generation.
  • Perform, oversee and work closely with in house or contracted staff to complete site visits for qualification, initiation, follow-up, or closure of a study such that an adequate GCP report may be filed at the completion.
  • Work closely and communicate regularly with departmental personnel on the status of assigned sites for all clinical trials.
  • Perform, oversee and work closely with in house or contracted staff to maintain device accountability records. Coordinate outgoing study supplies including study devices.
  • Provide feedback to management on the ongoing progress of assigned trials and study related activities.
  • Assist with the development and implementation of necessary operating procedures for department success.
  • Assist with all Adagio Medical regulatory submissions, as assigned.
  • Recognize and report trends and study difficulties that may impact outcomes. Participate in problem solving that defines a solution matrix for management discussion.

REPORTING

This position will report directly to the Director, Clinical Affairs. Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans. Duties may change to support revisions to corporate goals and immediate needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – B.S. in Life/Health Sciences, Nursing, or Engineering
  • Minimum – 5 to10 years industry experience in a medical device company (preferably Cardiology).
  • Minimum – 4 years experience working directly with physicians and healthcare professionals.
  • Desirable – Ability to present/teach detailed technical and clinical information, to all levels of company personnel and customers.
  • Desirable – Excellent communication, presentation, analytical, interpersonal and problem-solving skills. Powerpoint, MS Project, and EXCEL skills a plus.
  • Desirable – Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
  • Desirable – Experience in IDE clinical studies and working with an early start up company a plus.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Apply

JOB TITLE: Field Clinical Engineer
DEPARTMENT: Clinical Affairs
REPORTS TO: Director, Clinical Affairs

JOB SUMMARY

The primary responsibility of the Field Clinical Engineer is to manage assigned clinical sites during study start-up activities, study recruitment and treatment, and follow-up study phases of global clinical research, as assigned. Primary tasks would involve but not be limited to: The overall management of all aspects of the site regulatory process, clinical education and case coverage, data collection oversight, conducting site visits for initiation, site monitoring and closeout, maintaining device accountability, maintaining study records and communicating with appropriate site staff and investigators for the successful completion of Adagio Medical clinical studies. As the primary contact for all assigned sites, responsibilities will include the communication of related clinical information to departmental members plus the key personnel within Adagio Medical essential to R and D advancement. These tasks and responsibilities may be outsourced or completed within the department dependent on company needs. Additional duties may include activities outside of the job description, dependent on needs of Adagio Medical Inc.

The position requires a high level of innovative thought and problem-solving skills. Tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the Field Clinical Engineer is required to interact with multiple departments within the organization as well as investigators, site coordinators, IRB chairpersons, hospital staff and regulatory bodies. Domestic travel is a requirement and may be sporadic in nature. Occasional international travel may be required for training purposes and procedure coverage. Overall, it should be limited to less than sixty percent of the time.

DUTIES AND RESPONSIBILITIES

  • Participate in all aspects of the conduct of clinical trials (primarily US). Studies may include both pre market and post market studies.
  • Educate and train all assigned site participants on the proper use of Adagio Medical products thus insuring safe, efficacious use of Adagio Medical products.
  • Must be able to communicate current and relevant cardiac electrophysiology data, and trends as they relate to the appropriate use of Adagio Medical equipment and the treatment of our targeted study population.
  • Oversee assigned clinical cases including the catheter and console use, data collection and adherence to protocol.
  • Perform, oversee and work closely with in house or contracted staff to completely and accurately comply with GCP guidelines in the collection of study data.
  • Perform, oversee and work closely with in house or contracted staff to review, clarify and obtain data clarification (via DCRs) with site personnel. Assist in reviewing data listings and query generation.
  • Perform, oversee and work closely with in house or contracted staff to complete site visits for qualification, initiation, follow-up, or closure of a study such that an adequate GCP report may be filed at the completion.
  • Work closely and communicate regularly with departmental personnel on the status of assigned sites for all clinical trials.
  • Perform, oversee and work closely with in house or contracted staff to maintain device accountability records. Coordinate outgoing study supplies including study devices.
  • Provide feedback to management on the ongoing progress of assigned trials and study related activities.
  • Assist with the development and implementation of necessary operating procedures for department success.
  • Assist with all Adagio Medical regulatory submissions, as assigned.
  • Recognize and report trends and study difficulties that may impact outcomes. Participate in problem solving that defines a solution matrix for management discussion.

REPORTING

This position will report directly to the Director, Clinical Affairs. Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans. Duties may change to support revisions to corporate goals and immediate needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – B.S. in Life/Health Sciences, Nursing, or Engineering
  • Minimum – 5 to10 years industry experience in a medical device company (preferably Cardiology).
  • Minimum – 4 years experience working directly with physicians and healthcare professionals.
  • Desirable – Ability to present/teach detailed technical and clinical information, to all levels of company personnel and customers.
  • Desirable – Excellent communication, presentation, analytical, interpersonal and problem-solving skills. Powerpoint, MS Project, and EXCEL skills a plus.
  • Desirable – Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
  • Desirable – Experience in IDE clinical studies and working with an early start up company a plus.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Apply

JOB TITLE: Principal Process Development Engineer

DEPARTMENT:  Operations Engineering (Catheters)

REPORTS TO: Engineering Manager

Position Summary

The principal process development engineering position at Adagio Medical is an engineering professional with 10+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for providing guidance and oversight to multiple teams or individuals working on numerous products or developing various forms of medical device technologies. This individual is a leader who thinks strategically and has long-range company goals in mind and will manage all phases of technical projects. They will oversee the product or project conception, product design, product design documentation and manage scheduling, estimating and securing materials and vendors. The principal engineer will also conduct engineering studies and investigations and prepare reports for company leadership. They also provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.

Duties and Responsibilities:

  • Provide technical leadership for the design and development of medical devices
  • Assist in the transfer of new products from R&D to production
  • Establish processes and manufacturing documentation for new catheter products
  • Identify processes to fabricate new products
  • Use CAD software (Solidworks preferred) for part and assembly design and detailed drawings
  • Perform experiments to determine validity of designs
  • Provide technical leadership for development projects
  • Define product requirements
  • Design and development of tooling
  • Perform or manage design verification, equipment qualification and product and process validations
  • Prepare and maintain product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
  • Supervise and advise team members as necessary
  • Comply with applicable FDA and international regulatory laws/standards
  • Other duties as assigned or required

REPORTING

This position will report directly to the Engineering Manager.  Adagio Medical specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in biomedical or mechanical engineering
  • Minimum – Ten (10) years of experience working in the medical device industry
  • Minimum – Knowledge of FDA/MDD regulations as they relate to Class III medical devices
  • Minimum – Demonstration of excellent communication skills (written and oral)
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – Prior experience with non-invasive medical devices (catheters)
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Ability to present/teach detailed technical information to all levels of company personnel and customers
Apply

JOB TITLE: Regulatory Manager

DEPARTMENT: Regulatory

REPORTS TO: VP RA/QA

Position Summary

The primary responsibility of the regulatory manager is to manage and perform regulatory submissions for local and worldwide regulatory agencies.  The RA manager is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance. The position requires a high level of innovative thought and problem-solving skills.  Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the regulatory specialist is required to interact with multiple departments within the Adagio Medical organization as well as regulatory bodies.

Duties and Responsibilities:

  • Develops strategies and implements plans to obtain FDA Approvals, CE Mark and other foreign regulatory approvals.
  • Manage and prepare regulatory submissions and registrations (FDA and EU regulatory entities)
  • Oversee IDE, PMA, 510(k), Design Dossiers, Technical Files, and other regulatory filings.
  • Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.
  • Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
  • Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies.
  • Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
  • Perform additional duties as required

REPORTING

This position will report directly to the VP, Quality and Regulatory Affairs.  Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.

JOB QUALIFICATION REQUIREMENTS

  • Bachelor’s degree (B.S.) from four-year College or University.
  • Five (5) years minimum experience in regulatory affairs.
  • Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to company products.
  • Knowledge and understanding of Quality and Regulatory concepts and application
  • Strong analytical, planning and organizational skills
  • Strong interpersonal and communications skills (oral & written)
  • Self-starter with ability to work independently under pressure and react quickly to changing priorities
  • Proficient in MS Office products.
Apply

JOB TITLE: Principal FEA Engineer

DEPARTMENT: Research and Development (Catheters)

REPORTS TO: Engineering Director

Position Summary

The principal FEA engineering position at Adagio Medical is an engineering professional with 10+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for providing guidance and oversight to multiple teams or individuals working on numerous products or developing various forms of medical device technologies. This individual is a leader who thinks strategically and has long-range company goals in mind and will manage all phases of technical projects. They will oversee the product’s or project’s conception, product design, product design documentation and manage scheduling, estimating and securing materials and vendors. The Principal FEA Engineer will also conduct finite element analysis simulations, engineering studies and investigations and prepare reports for company leadership. They also provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.

Duties and Responsibilities:

  • Lead finite element analysis (FEA) simulations to guide overall system development
  • Provide technical leadership for the design and development of medical devices
  • Assist in the transfer of new products from R&D to production
  • Establish processes and manufacturing documentation for new catheter products
  • Identify processes to fabricate new products
  • Use CAD software (Solidworks preferred) for part and assembly design and detail drawings
  • Perform experiments to determine validity of designs
  • Provide technical leadership for development projects
  • Define product requirements
  • Design and development of tooling
  • Perform or manage design verification, equipment qualification and product and process validations
  • Prepare and maintain product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
  • Supervise and advise team members as necessary
  • Comply with applicable FDA and international regulatory laws/standards
  • Other duties as assigned or required

REPORTING

This position will report directly to the Engineering Director.  Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience.
  • Minimum – Ten (10) years industry experience with a medical device/pharmaceutical/biotechnology company
  • Minimum – Two (2) years of experience conducting FEA simulations with electromechanical medical devices using COMSOL or other FEA software
  • Minimum – Two (2) years supervisory experience
  • Minimum – Knowledge of FDA/MDD regulations as they relate to Class III medical devices.
  • Minimum – Demonstration of excellent communication (written and oral) skills
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – Prior experience with non-invasive medical devices (catheters).
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Ability to present/teach detailed technical information, to all levels of company personnel and customers.
Apply

JOB TITLE: Principal Quality Engineer

DEPARTMENT: Quality

REPORTS TO: Quality Engineering Manager

Position Summary

The primary responsibility of the quality engineer is to maintain, and support compliance activities associated with product manufacturing, non-conformance reports (MRB), customer complaints, product acceptance and release through active involvement & presence in the assembly operations. Continual improvement of methods & systems towards full compliance and world class manufacturing.

The position requires a high level of innovative thought and problem-solving skills.  Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success.   In addition to the above responsibilities, the quality engineer is required to interact with multiple departments within the Adagio Medical organization to ensure compliance to the Quality Management System (QMS).

Duties and Responsibilities:

  • Daily support of production requirements and issues through active involvement & presence in the assembly operations and clean rooms.
  • Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.
  • Maintain the CAPA system and files. Coordinate CAPA activities including investigations, root cause analysis, and implementation of corrective actions with effectivity analysis.
  • Develop quality assurance specifications, test devices & methods, inspection procedures, sampling plans and related written procedures.
  • Support new product launch, Risk Management Activities (FMECA), Master validation plans, product V&V, Process Validations, and Design Transfer into manufacturing.
  • Implement and review changes to existing products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
  • Support Internal Audit process and follow-up on Audit findings.
  • Manage the Supplier Evaluation and Qualification process. Work with purchasing to manage the qualification process of new suppliers and re-evaluation of existing suppliers.
  • Support & develop quality metrics and monitor production/product non-conformance trends in order to alert senior management of these trends so corrective actions can be implemented.
  • Recommends modifications of existing quality or production standards to achieve optimum quality and compliance.
  • Provide quality engineering support to quality control and provide guidelines on inspection methods and equipment used including measuring systems capabilities.
  • Complete projects in a manner consistent with corporate objectives.
  • Work with Manufacturing and Engineering teams to coordinate pilot production of new process validations and risk analysis activities.

REPORTING

This position will report to the Quality Engineering Manager. Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.

JOB QUALIFICATION REQUIREMENTS

  • Bachelor’s degree (B.S.) from four-year College or University.
  • Three (3) years minimum experience in quality engineering and quality assurance.
  • Current knowledge of FDA Quality System Regulations and Guidelines, ISO 13485, and standards applicable to company products.
  • Knowledge and understanding of Quality and Regulatory concepts and application
  • Strong analytical, planning and organizational skills
  • Strong interpersonal and communications skills (oral & written)
  • Self-starter with ability to work independently under pressure and react quickly to changing priorities
  • Proficient in MS Office products.
Apply

JOB TITLE: Catheter Assembler 2nd Shift

DEPARTMENT: Operations

REPORTS TO: Production Manager

JOB SUMMARY

The primary responsibility of the Assembly Technician for 2nd shift is to perform assembly line tasks as well as identify areas of improvement to increase efficiency.

 DUTIES AND RESPONSIBILITIES:

  • Assembles, repairs, inspect and/or test products following written instructions.
  • Work with a team to assemble entire products or components
  • Rotate through tasks for specific production processes
  • Conduct quality inspections on products and parts
  • Prepare finished products for shipment
  • Maintain a clean and orderly work area
  • Set up and operates a variety of machines following written instructions
  • Record information on approved documents.
  • Train other employees when necessary
  • Reads and interprets documents associated with the completion of assembly assignments. Utilizes knowledge of basic math, drawings.

REPORTING

This position will report directly to the Production Manager

JOB QUALIFICATION REQUIREMENTS

  • H.S. diploma or equivalent plus 2-5 years of related work experience or equivalent combination of education and work experience
  • Previous experience in manufacturing, assembly, or other related fields
  • Familiarity with assembly tools and equipment
  • Ability to handle physical workload
  • Ability to work well in teams
  • Ability to thrive in a fast-paced environment
  • Clean room experience and application of environmental procedures experience
  • Working knowledge of QSR and GMP
  • Qualified applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.
Apply

JOB TITLE:  Field Clinical Engineer – Europe

DEPARTMENT:  Clinical Affairs

REPORTS TO:  GM Europe

 

JOB SUMMARY

The primary responsibility of the Field Clinical Engineer is to manage assigned clinical sites during study start-up activities, study recruitment and treatment, and follow-up study phases of global clinical research, as assigned. Primary tasks would involve but not be limited to: The overall management of all aspects of the site regulatory process, clinical education and case coverage, data collection oversight, conducting site visits for initiation, site monitoring and closeout, maintaining device accountability, maintaining study records and communicating with appropriate site staff and investigators for the successful completion of Adagio Medical clinical studies.  As the primary contact for all assigned sites, responsibilities will include the communication of related clinical information to departmental members plus the key personnel within Adagio Medical essential to R and D advancement. These tasks and responsibilities may be outsourced or completed within the department dependent on company needs. Additional duties may include activities outside of the job description, dependent on needs of Adagio Medical Inc.

The position requires a high level of innovative thought and problem-solving skills.  Tasks will need to be prioritized and responsibilities delegated to ensure department success.  In addition to the above responsibilities, the Field Clinical Engineer is required to interact with multiple departments within the organization as well as investigators, site coordinators, IRB chairpersons, hospital staff and regulatory bodies.  Domestic travel is a requirement and may be sporadic in nature.  Occasional international travel may be required for training purposes and procedure coverage. Overall, it should be limited to less than sixty percent of the time.

DUTIES AND RESPONSIBILITIES

  • Participate in all aspects of the conduct of clinical trials (primarily US). Studies may include both pre market and post market studies.
  • Educate and train all assigned site participants on the proper use of Adagio Medical products thus insuring safe, efficacious use of Adagio Medical products.
  • Must be able to communicate current and relevant cardiac electrophysiology data, and trends as they relate to the appropriate use of Adagio Medical equipment and the treatment of our targeted study population.
  • Oversee assigned clinical cases including the catheter and console use, data collection and adherence to protocol.
  • Perform, oversee and work closely with in house or contracted staff to completely and accurately comply with GCP guidelines in the collection of study data.
  • Perform, oversee and work closely with in house or contracted staff to review, clarify and obtain data clarification (via DCRs) with site personnel. Assist in reviewing data listings and query generation.
  • Perform, oversee and work closely with in house or contracted staff to complete site visits for qualification, initiation, follow-up, or closure of a study such that an adequate GCP report may be filed at the completion.
  • Work closely and communicate regularly with departmental personnel on the status of assigned sites for all clinical trials.
  • Perform, oversee and work closely with in house or contracted staff to maintain device accountability records. Coordinate outgoing study supplies including study devices.
  • Provide feedback to management on the ongoing progress of assigned trials and study related activities.
  • Assist with the development and implementation of necessary operating procedures for department success.
  • Assist with all Adagio Medical regulatory submissions, as assigned.
  • Recognize and report trends and study difficulties that may impact outcomes. Participate in problem solving that defines a solution matrix for management discussion.

REPORTING

This position will report directly to the GM, Europe.  Specific duties will be determined and coordinated in conjunction with the company needs and strategic plans.  Duties may change to support revisions to corporate goals and immediate needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – B.S. in Life/Health Sciences, Nursing, or Engineering
  • Minimum – 5 to10 years industry experience in a medical device company (preferably Cardiology).
  • Minimum – 4 years experience working directly with physicians and healthcare professionals.
  • Desirable – Ability to present/teach detailed technical and clinical information, to all levels of company personnel and customers.
  • Desirable – Excellent communication, presentation, analytical, interpersonal and problem-solving skills. Powerpoint, MS Project, and EXCEL skills a plus.
  • Desirable – Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research
  • Desirable – Experience in IDE clinical studies and working with an early start up company a plus.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Apply

JOB TITLE: Catheter Assembler 1st Shift

DEPARTMENT: Operations

REPORTS TO: Production Manager

JOB SUMMARY

The primary responsibility of the Assembly Technician for 2nd shift is to perform assembly line tasks as well as identify areas of improvement to increase efficiency.

 DUTIES AND RESPONSIBILITIES:

  • Assembles, repairs, inspect and/or test products following written instructions.
  • Work with a team to assemble entire products or components
  • Rotate through tasks for specific production processes
  • Conduct quality inspections on products and parts
  • Prepare finished products for shipment
  • Maintain a clean and orderly work area
  • Set up and operates a variety of machines following written instructions
  • Record information on approved documents.
  • Train other employees when necessary
  • Reads and interprets documents associated with the completion of assembly assignments. Utilizes knowledge of basic math, drawings.

REPORTING

This position will report directly to the Production Manager

JOB QUALIFICATION REQUIREMENTS

  • H.S. diploma or equivalent plus 2-5 years of related work experience or equivalent combination of education and work experience
  • Previous experience in manufacturing, assembly, or other related fields
  • Familiarity with assembly tools and equipment
  • Ability to handle physical workload
  • Ability to work well in teams
  • Ability to thrive in a fast-paced environment
  • Clean room experience and application of environmental procedures experience
  • Working knowledge of QSR and GMP
  • Qualified applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.
Apply

JOB TITLE: Production Supervisor- 2nd Shift

DEPARTMENT: Operations

REPORTS TO: Production Manager

JOB SUMMARY

The Production Supervisor at Adagio Medical is a medical device professional with 5+ years of experience in medical device manufacturing. The qualified candidate will be responsible for production support and personnel supervision during 2nd shift manufacturing. Candidate must have strong leadership skills, adherence to manufacturing controls and QMS documentation requirements. Be able to provide direction as well as supervision/ discipline to the manufacturing assembly team.

DUTIES AND RESPONSIBILITIES

  • Review, update, and ensure team adherence to manufacturing process instruction, production travelers, and manufacturing methods.
  • Identify opportunities for improvements to process equipment, fixtures, and workspaces
  • Track production orders, build progress, yield data, and provide clear and accurate updates for management
  • Supports preventive maintenance and calibration of production equipment
  • Maintains product and company reputation by complying with regulations
  • Provides support for new product development and manufacturing
  • Experience with and use of ERP systems
  • Support product orders and shipping.
  • Comply with applicable FDA and international regulatory laws/standards
  • Other duties as assigned or required

REPORTING

This position will report directly to the Production Manager. Adagio Medical specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – High School Diploma or GED
  • Minimum – Five (5) years of experience working in the medical device industry
  • Minimum – Demonstration of excellent communication skills (written and oral)
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – Work closely with equipment and service vendors
  • Minimum – Good time and project management skills, good prioritization, and communication skills.
Apply

JOB TITLE: Senior Director, Clinical Affairs

DEPARTMENT: Clinical Affairs

POSITION SUMMARY

The primary responsibility of the Senior Director, Clinical Affairs is oversight and management of the conduct of global pre- and post-market clinical studies sponsored by Adagio Medical. Paramount in this responsibility is the strategic planning and efficient utilization of internal and external resources necessary to support clinical studies following all required national, regional, and local regulatory governance and Good Clinical Practice (GCP). Primary tasks would involve, but not be limited to: Development and management of highly-motivated personnel creating a cohesive Clinical Affairs department, assist with the strategic clinical investigational planning supportive of corporate objectives, clinical Investigational Plan (CIP) development, clinical study internal and external resource allocation, oversight on all data management activities pertaining to clinical studies, maintenance of departmental budgets, and , as requested, representation of the Clinical Affairs department at all regional and national regulatory body and society meetings. 

The position requires a high level of innovative thought, management, and problem-solving skills.  Tasks will need to be prioritized and responsibilities delegated to ensure department success.  In addition to the above responsibilities, the Senior Director, Clinical Affairs is required to interact with multiple departments within the organization as well as investigators, site coordinators, IRB chairpersons, hospital staff and regulatory bodies.  Domestic travel is a requirement and may be sporadic in nature.  Occasional international travel may be required for training purposes and international meetings. Overall, it should be limited to less than forty percent of the time.

DUTIES AND RESPONSIBILITIES

  • Oversee the Clinical Affairs departmental activities in support of global clinical studies following the Quality Management System
  • Direct all local, regional, and national activities in support of global clinical studies
  • Provide mentoring and direction for Clinical Affairs department members including setting goals that are aligned with corporate objectives, clinical project management and building high performance teams
  • Assume the Clinical Affairs department supervisory management role of, but not limited to, personnel hiring, periodic reviews, and expense control.
  • Perform, oversee, and work closely with internal and external resources to completely and accurately comply with GCP guidelines in the conduct of clinical studies.
  • Support the training of internal staff, study investigators and other site personnel on the proper conduct of the trial and the review of specific product performance specifications
  • Ensure the procedures and techniques are being properly performed by investigators, site personnel, and the clinical field team members to mitigate risks associated with study devices and patient management.
  • Problem solve and define a solution matrix for all clinical study issues as they arise.
  • Develop and maintain cost controls within the Clinical Affairs Budget
  • Communicate regularly with Sr. Leadership on the status of all ongoing clinical studies
  • Provide strategic feedback to Sr. Leadership on planned clinical activities in support of clinical objectives
  • Maintain a high level of product knowledge and scientific changes impacting the electrophysiology marketplace
  • Develop, periodically review, and implement necessary operating procedures for department success
  • Assist with all Adagio Medical Regulatory submissions, as requested

JOB QUALIFICATION REQUIREMENTS

  • Minimum – B.S. in Life/Health Sciences or Engineering. Advanced degree a plus.
  • Minimum – 10 years industry experience in a medical device company (preferably Cardiology).\
  • Minimum – 5 years experience directing a Clinical Affairs department\
  • Minimum – Demonstration of team building skills through previous work experience
  • Minimum – Demonstration of excellent communication, presentation, analytical, interpersonal and problem-solving skills through previous work experience. Powerpoint, MS Project, and EXCEL skills a plus.
  • Desirable – Ability to present/teach detailed technical and clinical information, to all levels of company personnel and customers.
  • Desirable – Familiarity with Good Clinical Practice, ISO, 21 CRF, and MEDDEV regulations pertaining to clinical research
  • Desirable – Experience in IDE clinical studies, PMA and MEDDEV submissions. Working with an early start up company a plus.
  • Desirable – Certification from an accredited GCP training program and a HIPPA compliance program
Apply

JOB TITLE: Senior Buyer

DEPARTMENT: Operations

REPORTS TO: Director of Operations

POSITION SUMMARY

The Senior Buyer position at Adagio Medical is an industry professional with 8+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for planning and executing procurement of raw materials from global suppliers. Maintain strong communication with manufacturing and key supplier to generate requests for quotation, establishing lead times, negotiating prices, writing purchase orders, and seeking approval. The individual will submit and track purchases orders while providing timely updates on delivery.

This position requires coordination of inventory planning and replenishment of raw materials and components across all products, The individual is a leader who thinks strategically and has long-range goals and forecasts in mind. Previous experience in medical device is a requirement, following GDP, GMP, all QMS systems and documentation is required. Also requires tracking of product orders, scheduling, and coordinating product shipments through package and freight services

DUTIES AND RESPONSIBILITIES

  • Review, update, and ensure team adherence to manufacturing process instruction, production travelers, and manufacturing methods.
  • Identify opportunities for improvements to process equipment, fixtures, and workspaces
  • Track production orders, build progress, yield data, and provide clear and accurate updates for management
  • Supports preventive maintenance and calibration of production equipment
  • Maintains product and company reputation by complying with regulations
  • Provides support for new product development and manufacturing
  • Experience with and use of ERP systems
  • Support product orders and shipping.
  • Comply with applicable FDA and international regulatory laws/standards
  • Other duties as assigned or required

REPORTING

This position will report directly to the Director of Operations. Adagio Medical specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in engineering, business, marketing, or similar field
  • Minimum – Five (5) years of experience working in the medical device industry
  • Minimum – Demonstration of excellent communication skills (written and oral)
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Desirable – Prior experience with a medical device company
  • Desirable – Ability to present/teach purchasing processes, shipping processes, and inventory management
Apply

JOB TITLE: Sr. Console Manufacturing Engineer

DEPARTMENT: Operations

REPORTS TO: Director of Operations

 

JOB SUMMARY

The primary responsibility of the Electromechanical Manufacturing Engineer is the production support, troubleshooting, and process improvement of the Cryoablation Console. Included in these tasks are; understanding the electrical and mechanical design, improving the manufacturing processes and procedures, support technicians with troubleshooting and resolution of manufacturing and design issues, and implementing equipment and fixture improvements. This position requires a high level of organization and documentation skills, and attention to detail.

DUTIES AND RESPONSIBILITIES

  • Hands on Assembly of electronics, wiring, and support of electronics and mechanical manufacturing.
  • Ensures all equipment has PM, Cal, IQ, OQ, PQ completed and is properly labeled.
  • Being liaison between R&D and manufacturing for current and new projects
  • Updating manufacturing documents WI, FRMS, IP, DOP as needed
  • Manages all production documentation, keeping all revisions current on production floor, providing guidance on training
  • Work closely with R&D to develop and transfer next generation products to production
  • Review and updates manufacturing process instructions and ensuring assemblers adhere to proper manufacturing methods
  • Identify opportunities for production equipment, fixtures, and tooling improvements
  • Ensuring optimal manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout
  • Provides manufacturing decision-making information by reviewing production schedules, estimating future requirements, providing manufacturing progress updates
  • Maintains product and company reputation by complying with government regulations
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures; requesting special service
  • Maintains product and company reputation by complying with government regulations
  • Working with machine shop for information on components
  • Participates in team meetings, provides feedback about manufacturing, process improvements
  • Develops creative and innovative ways to organize the production area, maximizing utilization of space.
  • Maintains a safe and clean working environment
  • Maintains product and company reputation by complying with government regulations

REPORTING

This position will report directly to the Director of Operations. Adagio Medical Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.

JOB QUALIFICATION REQUIREMENTS

  • College graduate with BS in Manufacturing, Industrial, Biomedical, or Mechanical Engineering
  • Medical Device Internship Experience
  • Electromechanical design and assembly experience
  • Skilled in using Microsoft programs including Excel, Share Point.
  • Must be fully trained and possess demonstrated ability to meet established standards in the manufacturing processes established for this specific area.
  • Familiarity with quality control system in a Good Manufacturing Practices (GMP) environment is required.

SKILLS

  • Ability to work under pressure and exercise flexibility as needed. Act independently and exercise sound judgement; maintain confidentiality in all matters related to employees.
  • Effective oral and written communication skills.
  • Ability to ensure accurate and timely preparation of various required documentation.
  • Ability to establish and maintain effective cooperative relationships.
  • Ability to identify problems and develop creative solutions both independently and in cooperation with others.
  • Work with and provide feedback to various departments and customers; Engineering, Operations, Quality, and Purchasing.
  • Ability to prioritize effectively in a dynamic work environment.
  • Escalates issues appropriately and follows through to completion.
  • Good knowledge of Quality System requirements.
  • Attention to detail and accuracy.
Apply

JOB TITLE:  Staff Console Development Engineer

DEPARTMENT:  Research and Development (Console)

REPORTS TO:  Engineering Manager

JOB SUMMARY

The staff console development engineering position at Adagio Medical is an engineering professional with 7+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for providing guidance and oversight to multiple teams or individuals working on numerous products or developing various forms of medical device technologies. This individual is a leader who thinks strategically and has long-range company goals in mind and will manage all phases of technical projects. They will oversee the product or project conception, product design, product design documentation and manage scheduling, estimating and securing materials and vendors. The staff console development engineer will also conduct engineering studies and investigations and prepare reports for company leadership. They also provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.

Principal engineering level can also be considered commensurate with level of experience.

DUTIES AND RESPONSIBILITIES

  • Provide technical leadership for the design and development of new console platforms
  • Assist in the transfer of new console design from R&D to production
  • Establish processes and manufacturing documentation for new console platforms
  • Identify processes to fabricate new consoles
  • Use CAD software (Solidworks preferred) for part and assembly design and detailed drawings
  • Perform experiments to determine validity of designs
  • Provide technical leadership for development projects
  • Define product requirements
  • Design and development of tooling
  • Perform or manage design verification, equipment qualification and product and process validations
  • Prepare and maintain product documentation including DHF, drawings, BOM, test protocols and reports, DCOs, etc.
  • Supervise and advise team members as necessary
  • Comply with applicable FDA and international regulatory laws/standards
  • Other duties as assigned or required

REPORTING

This position will report directly to the Engineering Manager.  Adagio Medical specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – Bachelor’s Degree in biomedical or mechanical engineering
  • Minimum – Seven (7) years of experience working in the medical device industry
  • Minimum – Five (5) years of experience working in medical device capital equipment development
  • Minimum – Knowledge of Electrical Safety and EMC regulations as they relate to Class III medical devices
  • Minimum – Knowledge of FDA/MDD regulations as they relate to Class III medical devices
  • Minimum – Demonstration of excellent communication skills (written and oral)
  • Minimum – Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Minimum – Prior experience with non-invasive medical devices and related capital equipment
  • Desirable – Prior experience with a start-up medical device company
  • Desirable – Ability to present/teach detailed technical information to all levels of company personnel and customers
Apply

JOB TITLE:  R&D Technician

DEPARTMENT:  Research and Development (Catheters)

REPORTS TO:  Engineering Manager

JOB SUMMARY

The primary role of the R&D Technician is to provide catheter prototyping and device assembly support to the engineering team. The R&D Technician periodically conducts verification testing to assess the functionality of catheter prototypes. The R&D Technician trains production assembly team members for pre-production/production of new catheter designs. The ideal candidate is a seasoned expert production assembler ready to move from the medical device production environment into the R&D lab.

DUTIES AND RESPONSIBILITIES

  • Proficient with catheter manufacturing tools and practices (hot torches, adhesives, shrink tubing, tubing cutters etc.)
  • Strong problem solving skills, independent thinker, and attention to detail 
  • Comfortable working with small parts and subassemblies by using templates or measurements
  • Assemble/fabricate components, examine/evaluate connections for fit
  • Verify specifications by measuring completed components
  • Resolve assembly problems, and communicate all problems with R&D engineering
  • Keeps equipment operational by ensuring all have the proper asset and calibration labels
  • Maintain a safe and clean working environment by complying with company procedures, rules, and regulations
  • Maintain lab supply inventory by checking stock periodically to determine inventory level; anticipating needed supplies; communicates need to appropriate personnel
  • Documents all actions by completing R&D production and quality forms
  • Build prototypes for feasibility testing, animal studies and pilot manufacturing builds
  • Other duties as assigned or required

REPORTING

This position will report directly to the Engineering Manager.  Adagio Medical specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

JOB QUALIFICATION REQUIREMENTS

  • Minimum – At least 5-7 years of medical device assembly experience in a regulated (clean room) environment.
  • Minimum – Knowledge and experience using typical medical device measurement tools (calipers, rulers etc.)   
  • Minimum – Understanding of medical device quality management system and the inspection of products and components