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Medical Engineering
Technology Bucket (M) Sdn BhdKuala Lumpur, Kuala Lumpur, Malaysia1 day ago
Job descriptionBackground 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
Location : Kuala Lumpur
Industry : Medical
Key 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
Requirements :
Interested candidates, please email your resume to or call for more information at
Job Type : Full-time
Work Location : In person
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Engineering • Kuala Lumpur, Kuala Lumpur, Malaysia
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