Minimum of 10 years of progressive hands-on experience in medical device product development under FDA Quality System Regulation (21 CFR Part 820) and ISO 13485, with a demonstrated track record of successfully advancing complex electromechanical or electro-fluidic devices from concept through verification, validation, and commercialization. Effectively synthesize, condense, and communicate complex technical data, experimental results, trade-off analyses, and risk assessments through clear presentations, design reviews, and written reports for cross-functional audiences including R&D, Quality, Regulatory, Manufacturing, and senior leadership.