• Program Manager for Electronic Biomedical Devices

    University of Michigan (Ann Arbor, MI)


    Program Manager for Electronic Biomedical Devices

    How to Apply

    A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

    Job Summary

    The Program Manager will oversee the end-to-end development and regulatory approval of a cutting-edge biomedical device, including oversight and technical review of semiconductor chip fabrication, MEMS post-processing steps, encapsulation techniques, electrical system integration, safety testing, quality management and regulatory communications. The person in this role will coordinate cross-functional teams, external partners, and regulatory stakeholders. They are responsible for successful system integration, verification and testing, performance, quality, and safety assurance, and completion of all requirements for FDA approval submission. They will manage technical complexities and mitigate risks, develop detailed project plans, track milestones, and deliver the product on time and within budget.

     

    Who We Are

     

    Michigan Engineers are world-class educators, researchers, students and staff who strive to build a people-first future. As part of a top national public research institution, Michigan Engineering's mission is to provide scientific and technological leadership to the people of the world, develop intellectually curious and socially conscious minds, create collaborative solutions to societal problems, and promote an inclusive and innovative community of service for the common good.

     

    Why Work at Michigan?

     

    In addition to a career filled with purpose and opportunity, The University of Michigan offers a comprehensive benefits package to help you stay well, protect yourself and your family and plan for a secure future. Benefits include:

     

    + Generous time off

    + A retirement plan that provides two-for-one matching contributions with immediate vesting

    + Many choices for comprehensive health insurance

    + Life insurance

    + Long-term disability coverage

    + Flexible spending accounts for healthcare and dependent care expenses

    + Maternity and Parental Leave

    Responsibilities*

    + Collaborate closely with electrical, mechanical, software, and biomedical engineers to ensure cohesive system-level design and integration.

    + Serve as the primary point of contact between engineering, quality, and regulatory stakeholders.

    + Ensure compliance with all applicable standards (e.g., ISO 13485, IEC 60601-1, ISO 14708) and support the creation of design history files and technical documentation for FDA submissions.

    + Drive the preparation and execution of GLP preclinical testing, verification & validation, and regulatory submission strategies in accordance with FDA guidelines. Coordinate a team of experts and consultants to write FDA presubmission inquiries and an investigational device exemption.

    + Develop and maintain detailed project schedules, budgets, and resource plans across internal and external teams.

    + Perform design reviews and help resolve technical challenges for semi-conductor components, MEMS processes, PCB and embedded system design, and firmware design. Identify consultants as necessary to aid in design reviews.

    + Identify and mitigate technical and programmatic risks through proactive planning and cross-functional collaboration.

    + Help facilitate interaction with external stakeholders, including medical professionals and funding agencies.

    Required Qualifications*

    + Master's degree or Ph.D. in Engineering (Electrical, Biomedical, Mechanical, or related field), or equivalent combination of education and experience.

    + 10+ experience in product development and program management in the biomedical industry.

    + Excellent leadership, communication, and organizational skills, with the ability to manage multiple stakeholders and competing priorities.

    + Experience with regulated development processes including Design Controls, Risk Management (ISO 14971), and Quality Management Systems (ISO 13485).

    + Strong technical background and hand-on familiarity with semiconductor fabrication, CMOS digital and analog design, MEMS technologies, cleanroom processes and equipment, electrical system design, and embedded software.

    + Experience in device system validation for functional and parametric characterization.

    Desired Qualifications*

    + Experience with quality management systems and proven success in obtaining FDA approvals for Class III devices.

    + Knowledge of embedded software security requirements.

     

    Modes of Work

     

    Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .

     

    Background Screening

     

    The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.

     

    Application Deadline

     

    Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

     

    U-M EEO Statement

     

    The University of Michigan is an equal employment opportunity employer.

     

    Job Detail

     

    Job Opening ID

     

    262916

     

    Working Title

     

    Program Manager for Electronic Biomedical Devices

     

    Job Title

     

    Electrical Eng Staff Spec

     

    Work Location

     

    Ann Arbor Campus

     

    Ann Arbor, MI

     

    Modes of Work

     

    Onsite

     

    Full/Part Time

     

    Full-Time

     

    Regular/Temporary

     

    Regular

     

    FLSA Status

     

    Exempt

     

    Organizational Group

     

    College Engineering

     

    Department

     

    EECS - ECE Division

     

    Posting Begin/End Date

     

    4/30/2025 - 5/14/2025

     

    Salary

     

    $155,000.00 - $165,000.00

     

    Career Interest

     

    Engineering & Architecture