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 arrythmias are being treated.

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

Open Positions

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JOB TITLE: Clinical Trial Manager
DEPARTMENT: Clinical Affairs
REPORTS TO: Director, Clinical Affairs

JOB 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 Director, 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 – Four (4) years industry experience with a medical device/pharmaceutical/biotechnology company
  • 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: 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: Director, Clinical Affairs
DEPARTMENT: Clinical Affairs
REPORTS TO: VP Clinical Affairs

JOB SUMMARY

The primary responsibility of the 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 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

REPORTING

This position will report directly to the VP, 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.

QUALIFICATION REQUIREMENTS

  • Minimum – B.S. in Life/Health Sciences, Nursing, or Engineering. Advanced degree a plus.
  • Minimum – 5 to 10 years industry experience in a medical device company (preferably Cardiology).
  • Minimum – 3 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: Field Clinical Specialist
DEPARTMENT: Clinical Affairs
REPORTS TO: Director, Clinical Affairs

JOB SUMMARY

The primary responsibility of the Field Clinical Specialist 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 Specialist 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 Specialist
DEPARTMENT: Clinical Affairs
REPORTS TO: Director, Clinical Affairs

JOB SUMMARY

The primary responsibility of the Field Clinical Specialist 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 Specialist 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 Specialist
DEPARTMENT: Clinical Affairs
REPORTS TO: Director, Clinical Affairs

JOB SUMMARY

The primary responsibility of the Field Clinical Specialist 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 Specialist 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:  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:  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.