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).

• 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

• 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)
• Ability to read and interpret engineering specifications, drawings, and BOMs