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).

Education

Any Gradute