You will own the quality and design transfer process for supplier components.
Responsibilities
- Collaborate with engineering and cross-functional teams on design packages.
- Work with suppliers to clarify requirements and answer technical questions.
- Drive design changes (ECOs) to incorporate alternate or approved suppliers.
- Manage verification of transferred items and First Article Inspections (FAIRs).
- Partner with Modality engineers to scope and assess transfer impact.
Required Skills
- 5+ years of professional engineering experience.
- Background in Mechanical or Electrical Engineering.
- Solid understanding and hands-on experience with Medical Device Quality Management System (QMS) processes.
- Proven experience managing end-to-end design change projects.
- Ability to read and interpret engineering specifications, drawings, and Bills of Material (BOMs).
- Experience covering the entire design change lifecycle (Inputs, Requirements, Verification, Transfer).