US_East | Mechanical & Physical Engineer_L

Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential

TMR D

Role:
Supplier Quality & Design Engineer

Work location:

Waukesha, WI

Background and Meet and Greet: MANDATORY

• 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 Materials (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.