Quality & Design Engineer

Summary : Develop qualification plans for supplier transfer projects and complete associated verification testing. Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs). Roles & Responsibilities: Collaborate effectively within engineering and cross-functional teams. Pull together design packages including drawings, specifications, and Bill of Material (BOM) Work with suppliers to understand requirements and answer technical questions Drive design changes (ECOs) to add alternate supplier or change the approved supplier Drive verification of transferred items and First Article Inspections (FAIRs) Partner with Modality engineers to understand scope and impact of the transfer Education & Experience : Background in Electrical or Mechanical Engineering (mix of Mechanical& Electrical Engineers ideal). Solid understanding of Medical Device Quality Management System (QMS) processes, with hands-on experience. Proven experience managing end-to-end design change projects. Electrical Engineering background, preferably with medical device knowledge Design Change experience (Inputs, Requirements, Verification, Transfer) bility to read and interpret engineering specifications, drawings, and BOMs