Expedite Talent Solutions · 2 days ago
US_East | Mechanical & Physical Engineer_L1
Expedite Talent Solutions is seeking a Supplier Quality & Design Engineer to support supplier transfer projects and manage engineering changes. The role involves collaborating with engineering teams, managing design packages, and ensuring compliance with quality management systems in the medical device sector.
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Responsibilities
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 Material (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
Qualification
Required
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
Company
Expedite Talent Solutions
Expedite Talent Solutions is a minority- and woman-owned firm delivering agile staffing, project outsourcing, and professional services to clients across the Healthcare, Commercial, and Public Sectors.