Over 20 years of medical device experience. My mechanical engineering and project management background as well as my passionate learning attitude served as my basis in the various functions I’ve taken in engineering, quality assurance, and regulatory affairs. I am also a successful individual and team contributor who has led an entire team to get the job done on time, within budget, within the various roles I played. I have developed relationships while creating and implementing quality systems from the ground up by working with various departments within the company to ensure that we have a quality system we can all follow and depend on. I have learned and worked alongside a multi-disciplinary, multi-functional team in start-ups and small/mid-size companies to take a product from concept, pre-IDE, IDE clinical trials, pre-submissions, and through the 510(k) clearance including post-market surveillance reporting, complaint handling, medical device reporting (MDR), and post-market clinical study – 522