Position Overview

This position is responsible for leading the investigations of returned devices to evaluate field performance of the devices in compliance with corporate procedures and applicable regulations (FDA 21 CFR Part 820.198, FDA 21 CFR Part 803 and ISO13485). Develop and execute the necessary plans to integrate failure analysis test activities to ensure product reliability and overall product goals are met. Develop and execute necessary strategies related to the engineering functions to achieve department and company goals. Responsible for the management of the Product Evaluation laboratory and the day-to-day operations. The position requires management of direct reports, as well as interactions and collaboration with medical and global cross-functional professionals such as Marketing, Regulatory affairs, Research & Development, Operations and Clinical Research. Job duties:
  • Lead the daily operations of the Product Evaluation Laboratory functions and activities, manage the inventory and organization of laboratory materials, improve and maintain functionality of the equipment in place.
  • Provide oversight and coordinate all engineering groups and activities related to product investigations and support returned product analyses and failure investigation activities, assisting with or performing technical evaluations of the returned devices.
  • Manage a group of Engineers and Technicians that support product return investigations. Responsibilities include hiring, training, developing and conducting performance reviews for the staff. Participate in goal setting, budgeting and project planning process.
  • Responsible for complaint data trending, analysis process and execution, and identification of signal to further investigate.
  • Work cross-functionally to ensure optimal processes exist to support upstream and downstream customer needs.
  • Lead the development of standard work related to laboratory processes and the investigation of returned devices and ensure accuracy and consistency of complaint investigations through oversight and approval of completed investigations.
  • Lead investigation of issues raised through data trending or specific issues raised from escalation process.
  • Lead process and quality improvement initiatives.
  • Contribute to Risk Management activities, assist in support of regulatory audits and inquiries from internal business partners or regulatory authorities regarding product investigations. Participate in Quality Management, complaint data and CAPA reviews.
  • Perform additional duties as assigned.

    1. Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical Eng. preferred) or scientific discipline, or equivalent education and experience.
    2. Six (6) years of previous related experience.
    3. Minimum of two (2) years of management or leadership experience.
    4. Medical device industry experience required.
    Desired Qualifications
    1. Clinical experience or in-depth knowledge of interventional products and medical procedures are strongly preferred.
    2. Lean or Six Sigma improvement systems certification is strongly preferred Strong leadership skills and interpersonal communication skills.
    3. Experience in a laboratory environment is strongly preferred.
    4. Proven excellent technical writing and presentation skills.
    5. Strong analytical and critical thinking skills including statistical techniques.
    6. Problem-solving and troubleshooting skills.
    7. Excellent time management skills, with the ability to handle multiple and shifting priorities.
    8. Ability to effectively work cross-functionally with other departments including Quality,
    9. Research & Development, Operations/Manufacturing, Regulatory and Marketing.
    10. Knowledge of FDA GMP/GLP, FDA Quality System Regulation 21 CFR part 820 and 803, Medical Device Directive (MDD), ISO 13485.
    11. Computer proficiency in MS Office: Word, Excel, and PowerPoint.
    12. Ability to work with minimal supervision.