Sr. Project Manager – Medical Devices – NPD

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

• 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