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:  Machinist

DEPARTMENT:  Operations

REPORTS TO:  Director of Operations

 

JOB SUMMARY

The primary responsibility of the Machinist is to manage all aspect of machined part procurement. Included in these tasks are: Developing code, identifying, and procuring materials and tooling, maintaining equipment, maintaining a safe working environment, completing build documentation.

This position requires a high level of innovative through and problem- solving skills. Multiple tasks will need to be prioritized and maintain constants communication with supply chain.

In addition to the above responsibilities, the Machinist is required to interact with multiple departs within the Adagio Medical organization.

They will oversee the machined parts code and documentation and manage scheduling, estimating, and securing materials and vendors, and manage maintenance of all equipment in the machine shop. The Machinist will also provide guidance to engineering on machined parts development and keep abreast of industry trends and issues.

DUTIES AND RESPONSIBILITIES

  • Operates machine tools such as lathes, mills, hand tools, to produce metal and plastic parts to specifications
  • Use CNC Lathe and CNC Mill to machine components
  • Reviews electronic and written drawing specification
  • Determines machining tooling, equipment, build sequences for machining jobs
  • Helps determine best material to produce parts and fixtures
  • Works with Engineering to create machinable part models
  • Promotes safety in the machine shop for themselves and visitors
  • Maintains a safe and clean working environment
  • Works with supervisor to prioritize job orders
  • Lays out , measures and marks material stock as required for placement of cuts
  • Maintains inventory of cutting tools, machine consumables, generic raw stock material
  • Ensures all materials for production parts are received, inspected, released, and correctly labeled before use
  • Works with engineering to identify material and provide updates for component drawing
  • Develops programs to CNC machine components and fixtures
  • Measures, examines, and test completed components to detect defects and ensure conformance to specification, using precision instrumentation
  • Identify opportunities for equipment, fixtures, and tooling improvements
  • Ensuring optimal machine shop efficiency by analyzing and planning workflow, space requirements, and equipment layout
  • Monitors the feed and speed of machines during the machining process
  • 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

  • High School graduate or equivalent
  • Minimum 5 years’ experience in machine shop environment
  • 1-3 years’ experience in a lead role with the ability to lead, train, and troubleshoot
  • CNC: 1 year required
  • Machinist: 3-5 years required
  • Highly skilled in reading drawing specifications
  • Highly skilled in reading and reviewing machine programs
  • Minimum 1 year of medical device or other regulated product manufacturing experience required
  • Experience with cleanroom environments preferred
  • Highly skilled in reading and reviewing machine programs.
  • Experience performing 1st Article Inspection.
  • 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.
  • Experience using a microscope and/or other measurement/inspection equipment preferred. SKILLS
  • Knowledge of modern technology and field related terminology.
  • Knowledge of principles of technician training methods and techniques.
  • Knowledge of current safety standards related to machine shop environment.
  • 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 prepare and present reports and recommendations.
  • 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.
  • Ability to work on any shift requiring training/support.
  • Interpret Technical Drawings and use knowledge to setups, work holding fixtures, process steps and equipment and tooling selection
  • Setup and prove out processes on CNC Machines, Lathes, mills, and related CNC equipment.
  • Suggest selection of CNC metal cutting tools, drills, and end mills, inserts, etc.
  • Inspect machines parts using standard inspection equipment, height stands, micrometer, calipers, gauging, etc.
  • Conceptualize, design and manufacture part holding fixtures for low and high-volume manufacturing processes.
  • Troubleshoot and resolve manufacturing process issues, fixtures, machines, and tooling.
  • Work with and provide feedback to various departments and customers; Engineering, Operations, Quality, and Purchasing.
  • Monitor CNC processes and implement proactive solutions; process improvements, line flow, quality, and efficiency.
  • Research new manufacturing methods to maintain a competitive edge within the industry
  • Exceptional mechanical skills and aptitude
  • Must be able to work independently and/or in a Team environment. Effective communication and coordination skills.
  • Display leadership skills including a pro-active approach to managing processes, and example setting.
  • 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.
  • Intermediate software skills including Solidworks, Mastercam or equivalent, HSMWorks or equivalent, Word and Excel.
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 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: 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: 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:  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: 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 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 Production Lead/ Supervisor 2nd Shift

DEPARTMENT: Operations

REPORTS TO: Production Manager

JOB SUMMARY

Production Lead/ Supervisor for 2nd shift

DUTIES AND RESPONSIBILITIES:

  • As a Production Lead in our manufacturing, you will be responsible for working within the framework of a team and performing the following activities:
  • Coordinates production activities to ensure materials, documents and processes are compliant with the established company practices and procedures.
  • Assists with product flow and organization over production line
  • Providing leadership, direction, training and coordination.
  • Performing all manufacturing and production operations for your respective work area in various manufacturing environments
  • Using written and verbal instructions, assembles and packages product.
  • Following production schedules and meeting production and quality goals
  • Recognizes problems as they arise and interface with technicians, engineers or supervisor to find a solution
  • May assist in manufacturing prototypes for R&D
  • Additional duties as assigned

REPORTING

This position will report directly to the Production Manager

JOB QUALIFICATION REQUIREMENTS

  • H.S. diploma or equivalent plus minimum of 5 years of related work experience or equivalent combination of education and work experience
  • Previous experience in manufacturing, assembly, or other related fields leading or supervisor production.
  • 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
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: Clinical Trial Manager-U.S. and EU

DEPARTMENT: Clinical Affairs

REPORTS TO: Vice President, 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, study tracking and oversight, 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 communicate with multiple departments within the Adagio Medical organization as well as investigators, study coordinators, IRBs/ECs, hospital staff and regulatory bodies.  Some domestic and international travel will be required.

DUTIES AND RESPONSIBILITIES

  • Participate in drafting or editing protocols, CRFs, and other study related documents to support clinical studies
  • Maintain tracking files adequately to clearly communicate the status of trial activities (e.g. site qualification, site activation, enrollment, adverse events, protocol deviations, monitoring visits, data queries, etc.)
  • 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 (CROs, contract monitors, etc.) to completely and accurately comply with GCP guidelines in the collection of study data
  • Assist in reviewing data listings and query generation.
  • Perform, oversee and work closely with clinical department members and contracted staff to complete documentation for studies such that an adequate GCP report may be filed at completion
  • Work closely and communicate regularly with field team members and study site personnel on the status of the ongoing trials, monitoring needs, data queries and site-specific needs or questions
  • 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 and operations department members and contracted staff to maintain device accountability records. Coordinate outgoing study supplies including study devices.
  • Inform 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 Adagio Medical regulatory submissions
  • Recognize trends and study difficulties that may impact outcomes. Problem solve and suggest solutions for management discussion.

REPORTING

This position will report directly to the Vice President, 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 of industry experience with a medical device/pharmaceutical/biotechnology company working on regulated clinical trials
  • Minimum – Four (4) years of 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 IDE studies
  • Desirable – Prior experience with post-market studies
  • Desirable – Prior experience with clinical trials in Europe
  • 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 HIPAA compliance program
  • Desirable – Certification as a CRA by the Association of Clinical Research Professionals (ACRP) or CTP by The Society of Clinical Research Associates (SOCRA)
Apply

JOB TITLE:  Senior Document Control Specialist

DEPARTMENT:  Quality & Regulatory

REPORTS TO:  VP RA/QA

JOB SUMMARY

The primary responsibility of the Document Control Specialist is to manage the Adagio Medical document control change order process for the review, release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records.  Supports necessary compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.  Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success.   In addition to the above responsibilities, the Document Control Specialist is required to interact with multiple departments within the Adagio Medical organization to complete tasks in a timely manner.

DUTIES AND RESPONSIBILITIES

  • Manage the Document Change Order (DCO) Process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records per the Adagio’s Standard Operating Procedures.
  • Support the Change Control Board (CCB) to process DCOs, implement changes, complete product disposition, and complete all DCO activities in a timely manner.
  • Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.
  • Manage the employee training program and maintain the training matrix by working with the hiring managers to ensure current training records, job description, and employee records are incompliance with Adagio’s Standard Operating Procedures.
  • Maintain control of electronic and hard copy of documents for SOPs, product specifications and drawings, inspection and manufacturing procedures, clinical documentation and protocols, process validation, design control, marketing and educational material and test reports.
  • Maintain and update Master Document List and Document Change Control Logs to ensure consistency and record keeping.
  • Support and Maintain Design History Files, Regulatory Technical files, Device Master Records, and other Design Dossier documents.
  • Assist with internal audits in compliance with the company’s internal audit procedure
  • Maintain the quality systems databases for the purposes of providing quality metrics data on routine basis or as required.
  • Prepare quality system trending information and prepare data summaries for management review meetings and other similar meetings as needed
  • Assists the Management Representative during external audits (FDA, Notified Body, California State Department of Public Health)
  • Support the VP of QA/RA during product development projects to ensure compliance and regulatory requirements are met throughout the development process.
  • Other duties as assigned or 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 document control.
  • Current knowledge of Medical Device Regulations (ISO 13485) and FDA Guidelines.
  • 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: Stockroom Clerk

DEPARTMENT: Operations

REPORTS TO: Senior Buyer 

JOB SUMMARY      

The primary responsibility of the Stockroom Clerk is to manage all the console component inventory. Included in these tasks are; procuring and filling work orders, maintaining an organized and clean stock room, and ensuring accurate inventory through cycle counts and work order transactions.

This position requires a high level of organization and documentation skills, and attention to detail. Multiple tasks will need to be prioritized and maintain constants communication with supply chain.

DUTIES AND RESPONSIBILITIES

  • Receive items to stock room, stock materials, update inventory spreadsheets
  • Verify accuracy of inventory through cycle counts
  • Pull work order number, create work order documents from released production travelers
  • Fill work order with parts from stock room, transact material from system
  • Filling floor stock bins, Kanban bags
  • Work with purchasing on ordering material
  • Maintains stock room, organization, ensures all material labelled, ensures room is clean
  • Maintains product and company reputation by complying with government regulations
  • Working with machine shop for information on components
  • Participate in team meeting, provides feedback about inventory, receiving inspection
  • Develops creative and innovative ways to organize the stock room, maximizing utilization of space.
  • Maintains a safe and clean working environment
  • Works with supervisor to prioritize job orders
  • Maintains product and company reputation by complying with government regulations

REPORTING

This position will report directly to the Senior Buyer.  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

  • High School graduate or equivalent
  • Minimum 1 year of experience in stockroom.
  • Medical device experience a plus
  • 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.
  • Experience using a microscope and/or other measurement/inspection equipment preferred.

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