With 30 years project management & product development experience to share, Michael has designed & developed many medical & consumer products including products in these areas:
|+| orthopaedic bracing || knee | spine | foot | shoulder | elbow
|+| dental || orthodontic brackets | elastics | facebows | accessories
|+| diabetes || hand-held glucose meter
|+| fly fishing || fly storage box
|+| swimming pools || zipper + disposable pool cleaner bags | sheet metal control box
|+| ear thermometer || anti-theft tether for hospitals
|+| ophthalmic || vitreoretinal surgical kits | surgical drape organizer | accessories
|+| Design and Development of Electromechanical products (Glucometer and Pool Controller) required integration of input/requirements from a variety of technical disciplines, including mechanical, software, electrical, chemists, manufacturing, and field service.
|+| Successful history of leading global cross-functional teams to develop products satisfying Product Specifications and Design for Manufacturability and Assembly (DFMA) requirements.
|+| History of developing products from concept-to-carton that have met or exceeded design, budget, cost and time targets.
|+| Proven expertise negotiating Product Specifications from Marketing and Key Opinion Leaders (KOLs).
|+| Research, Analysis, and Report writing skills: Product feasibility || Test Protocols and Reports || Intellectual Property (IP) research.
|+| Expertise in developing Class II (and some Class III experience) products following FDA's QSR and ISO-13485, including (but not limited to) the following aspects of development:
|| Defining/Maintaining Product Specifications
|| Design History File (DHF) Maintenance
|| Ensuring material biocompatibility [per ISO-10993]
|| Performing Risk Analysis [DFMECA, FMECA]
|| Holding regular project meetings and Design Reviews
|| Performing Verification and Validation (V&V)
|+| University of California, San Diego, Project Management Certificate | GPA 4.0
|+| University of San Diego | MBA International Business/Marketing
|+| University of California, San Diego | MS Bioengineering
|+| University of California, San Diego | BS Bioengineering
|+| 7,029,583 Hose Clasp for a Pool Cleaner Filter Bag [Polaris Pool Systems/Zodiac]
|+| 7,273,546 Disposable Filter Bag for a Pool Cleaner [Polaris Pool Systems/Zodiac]
|+| 6,551,264 Patella Tracking Orthosis [Breg]
|+| 5,842,567 Quick-Release Packaging [Alcon Surgical]
|+| 5,174,754 Orthodontic Bracket [Johnson & Johnson/”A”-Company]