ALTEN Technology USA - Electrical Design Engineer (medical devices)
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Requirements
• 3+ years of experience and background in Electrical Engineering. • 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 • Self-learner with the ability to quickly understand and work through complex designs • Proven track record of leading complex design supplier transfers as a RDE (responsible design engineer ), not SQE • Ability to proactively identify risk areas and work closely with suppliers to develop and execute mitigation plans • Location: on-site in Waukesha, WI • Location:
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 • Address all supplier technical questions with minimal support from SMEs • Independently lead technical discussions with suppliers and drive issue resolution.
Benefits
• The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience
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