Ecocareers ยท 1 month ago
Quality & Design Engineer
Waukesha, WI
Full-time
Onsite
Mid LevelConfidential company is seeking a Quality & Design Engineer to develop qualification plans for supplier transfer projects and manage Engineering Change Requests. The role involves collaborating with engineering teams, creating design packages, and driving design changes to ensure compliance and quality in medical device projects.
Staffing & Recruiting
Responsibilities
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase