Senior bio-medical engineering management professional with extensive experience in manufacturing, test and quality disciplines for Class 2 and 3 medical devices. I have background in lean manufacturing (6S), Six Sigma, bench level product validation/Verification and protocol development and line setup and configuration. Most recently at Stryker I held the position of Senior Quality Engineer responsible for CAPA, NCMR and IQA areas both at Fremont and Mountain View facilities. During my tenure at Boston Scientific, I held both management and individual contributor roles. I was the Sustaining Engineering manager for medical device manufacturing where I supported production, repair, R&D and the quality organizations. I also held the position of Sr. Principal Engineer having responsibility for protocol, process and training covering NPI and production class 2 and 3 medical devices. Additional job functions included CAPA management, FMEA support and subcontract supplier management. I recently held the position of Test Engineering Manager for Flextronics Medical and Creation Technologies. In my most recent position as Director of Engineering I had responsibility for delivering medical products ranging from ultrasound (Zonare) and pain management systems (Nevro) to medication delivery systems (AcelRx). Most recently at Scanadu I managed the test development for the Scout and the Scanaflow products including V&V as well as development of high volume production test systems.
Listed skills include R&D, Failure Analysis, Electronics, Spc, and 12 others.