Chief Technology Officer
Michael is an Electrical and Biomedical Engineer with over 25 years of experience in managing full life cycle product development and commercialization in the medical device industry. Mike has expertise in all phases of product development, including clinical inputs, product definition, system architecture, detailed product development in electrical, mechanical, chemical and systems engineering, V&V testing, regulatory submissions and design transfer for manufacturing. Mike has guided numerous projects through the entire development cycle from concept, through development, regulatory approval for both CE Mark and FDA clearance and into manufacturing and commercialization.
Mike has managed small and large engineering teams in numerous complex medical device projects, primarily for Class II and Class III medical device systems. Over his career, he has led the successful development and clearance of more than 10 FDA 510(k) cleared products and several systems requiring full PMA approval. He has also managed process development, manufacturing transfer and manufacturing support teams responsible for transitioning products from prototype to initial production runs, through process validation into long term serial production. Mike has diverse and broad experience in all aspects of medical device product development.
Prior to Matrix Medical, Mike served as the Director of Engineering for Valtronic, a medical device design and manufacturing company specializing in complex electromechanical systems. In this role he oversaw the manufacturing transfer and product of dozens of successful medical products. He was previously the Director of R&D at Greatbatch Medical/Nuvectra responsible for the ground-up development and commercialization of a novel 24-channel, fully implantable neurostimulation system with applications in the treatment of chronic pain, overactive bladder and DBS applications for movement disorders. Prior to Greatbatch, Mike was the VP of Engineering for BIOMEC, where he grew and managed a startup engineering team through the submission, receipt and execution of over $30M in NIH funding for various product development programs, prior to BIOMEC’s eventual acquisition.
Mike earned a Bachelor of Science degree in Electrical Engineering from Worcester Polytechnic Institute and a Master of Science in Biomedical Engineering from Case Western Reserve University. He holds more than a dozen patents in the medical device field, and has presented and moderated multi-disciplinary panel discussions at several conferences and industry trade shows