Accomplished executive with 20+ years of extensive experience driving product development and operational excellence. Pioneering, creative product developer and designer known for steering complex, high-tech products nationally and internationally. Powerfully effective team leader adept to conceptualize and deliver strategies to propel future growth and maximize the profits. Proven expertise in product development, risk management, V&V, design transfer, contract management, global development and production outsourcing, and cultivating high-performing multi-disciplined geographically distributed effective multi-country teams. Developed, released and mass produced 29 complex high-tech products to US and international markets (FDA Class1, Class2 medical devices, medical imaging systems, X-Ray imaging, Ultrasound imaging, Computed (CR) and Digital (DR) radiography, ophthalmic, neuro- cardio- vascular systems, laboratory equipment, NDT particle sizing DLS scientific instrumentation, sensing and data acquisition systems and devices, including mobile device connected cloud based skin care quantitative diagnostic platform, AI and ML aided ophthalmic diagnostic system).Accomplishments : • In 2 years increased revenues by 70% with release of six products while supporting merging with an industry leader• Despite founders conflict resulting in a fundamental investors disagreement, rebuilt the development groups, urgently finished the product design and successfully transferred design to offshore mass production • Led engineering and operations for successful $90M Series A funding of an innovative medical device company • In 8 months finalized product design, verified the performance, transferred to contract manufacturer in China and successfully pilot run 2000 multi-modality imaging skin care and diagnostic devices with 100k+ ramp up capacity• Succeed in deployment of FDA compliant design controls and QMS in medical device companies• Succeed in mass production in China, Malaysia, Thailand with global distributionAreas of Expertise :• Product Development• Operations & Production• Medical Devices• FDA, MDR and regional • Contract Manufacturing• Remote and globally distributed development and operations teams• AI and ML in medical applications• Structural, Spectroscopic, Ultrasound and Radiographic medical imaging • Laboratory and Scientific instrumentation • Startups • Budgeting & Financial• Supply and distribution chains • COGS and Process optimization• ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601, IEC 601010