Description

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).

Key Skills

Education

Any Gradute