Position Overview

The Device Risk Manager is responsible for defining, implementing and maintaining device risk management activities. These activities ensure that product risk is appropriately assessed, documented and mitigated throughout the entire product life cycle. Job duties:
  • Develop procedures which govern all product risk activities. Ensure product risk management procedures and practices incorporate applicableregulations and guidance documents including ISO 14971, 21CFR820 and EU MDR.
  • Provide guidance to other associates on the application of appropriate risk management practices. Work closely with associates in product development, production, quality engineering, regulatory affairs, quality systems and post-market surveillance.
  • Establish appropriate practices for assessing risk during product development activities. Support preparation of the risk management plan. Support preparation of failure mode effect analysis (FMEA) documents to assess potential risks from various sources. Developed FMEAs shall include those for product design (dFMEA), device use (uFMEA) and supplied components (sFMEAs).
  • Establish appropriate practices for assessing risk resulting from manufacturing activities. Support preparation of process failure mode effect analysis (pFMEA) documents.
  • Implement practices to update risk management documents throughout the product life cycle. Establish practices for revising FMEAs as appropriate when new information affecting product risk is available. FMEA updates shall include; a) incorporating production quality data into pFMEAs on a continual basis; and b) incorporating customer experience and field data into appropriate risk documents.
  • Support risk management practices and applicable documentation during internal audits and third-party inspections.
  • Performs additional responsibilities as assigned.
    1. Must have a bachelor’s degree in engineering or other relevant discipline, or equivalent experience.
    2. Expertise in global regulations pertaining to risk assessment. Experience in the application of applicable risk management regulations and guidance documents, including ISO 14971, 21CFR820 and EU MDR.
    3. Experience in medical device product development and manufacturing.
    4. Proficient at transferring medical device regulatory requirements into practice. Ability to translate regulation requirements into practical procedures.
    5. Must have five (5) or more years of experience in medical device quality engineering, product development or product manufacturing.
    6. Must have two (2) or more years of experience in management or in leading teams.
    7. Must have two (2) or more years of experience in project management.
    8. Ability to write and review procedures.
    9. Ability to lead complex technical projects.
    10. Ability to work effectively and confidently in a team environment.
    11. Excellent written and verbal communication skills.
    12. Proficient with MS Excel, Word, and Project.
    Desired Qualifications
    1. Ability to successfully manage large projects with ability to motivate cross-functional teams to complete their assigned tasks.
    2. Demonstrated skills in project management.