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Sr. Project Manager - Medical Devices - NPD

Company: Job Juncture
Location: San Jose
Posted on: October 24, 2019

Job Description:

Sr. Project Manager - Medical Devices - NPD

Medical Devices design and development company seeks a-- Sr. Project Manager to manage complex medical device product development programs from concept through production. --The Sr. Project Manager will work closely with clients and internal engineering teams, developing and maintaining project timelines and deliverables.-- Candidates should have a depth of experience in the development of complex medical electromechanical medical devices.-- The ideal candidate will have full product development life cycle experience from conceptualization to market launch.----

Requirements:


  • Bachelor's degree in engineering; advanced degree preferred
  • 7+ years of progressive experience in medical device development
  • 5+ years experience in program management of complex electromechanical medical devices.
  • Strong program management and project leadership experience and a track record of accomplishment in driving multiple medical device products, working with individual clients, through the development stages

    The ideal candidate will have:----

    • Experience with system design requirements
    • Experience with system level verification and validation--
    • Risk Assessment, 510K and PMA submission experience
    • FDA and notified body audit experience
    • Product transfer to manufacturing and post market support
    • ISO 13485 Quality systems and ISO 14971 Risk Management experience
    • Experience with AAMI/BSI/IEC Standards (60601)
    • FDA Inspection approach (QSIT) and FDA medical device regulations - 21 CFR820
    • Experience with Matlab, LabView, C, C++ and LabWindow--

Keywords: Job Juncture, Madera , Sr. Project Manager - Medical Devices - NPD, Executive , San Jose, California

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