Keith Faucher, MBA, PhD
About Keith Faucher, MBA, PhD
Senior R+D leader with over 17 years-experience in the medical device industry with Class I/Class II/Class III medical devices and combination products. A candidate with analytical, strategic, and cross-functional team-building qualities with the ability to work independently and manage multiple projects. Strong background in front-end innovation, product development, test method development and validation, medical device coatings, combination products, project management, laboratory management, biomaterials, polymer analysis, biocompatibility, and extractable/leachable testing. Innovator of new product technologies with over 25 granted US patents. Ability to manage internal and external resources, such as CROs and CMOs, to achieve project objectives. Experience hiring, building, and mentoring cross-functional project teams. Skills: Product development, project management, laboratory management, risk assessment, intellectual property, analytical method development and validation, supportive engineering, CAPA investigations, product complaints, biocompatibility (ISO 10993), process investigations, 510(k) and pre-IDE/PMA submissions.