Expedite Technology Solutions
US_East | Mechanical & Physical Engineer_L1
Expedite Technology Solutions, Waukesha, Wisconsin, United States, 53188
Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential
TMR ID: 3WT06D
Role: Supplier Quality & Design Engineer
Work location: Waukesha, WI
Background and Meet and Greet: MANDATORY
Job Description
Develop qualification plans for supplier transfer projects and complete associated verification testing.
Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
Key Responsibilities
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.
Mandatory Skills and Skill Proficiencies
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.
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TMR ID: 3WT06D
Role: Supplier Quality & Design Engineer
Work location: Waukesha, WI
Background and Meet and Greet: MANDATORY
Job Description
Develop qualification plans for supplier transfer projects and complete associated verification testing.
Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
Key Responsibilities
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.
Mandatory Skills and Skill Proficiencies
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.
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