Med device sustenance engineer
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Med device sustenance engineer
Location: Bengalore
Exp: 5Yrs
Skill Combination: Med device sustenance engineer SolidWorks QMS DHF documentation VnV PDMPLM
Qualifications / Requirements
- Bachelors Degree in Mechanical Engineering or a related field.
- Experience in medical domain ( electro mechanical products-- class II and class III).
- Hands on exp in SolidWorks and Siemens NX Design for manufacturability and serviceability for plastics and sheet metal exp in Stack-up analysis.
- Regulatory compliance alignment knowledge including ISO 13485 IEC 60601 ISO 14971 Understanding of FDA design control requirements (21 CFR 820.30).
- Working experience in EUMDR requirements ( Gap assessment and remediation).
- Experience in FMEA Verification and Validation testing. Develop Test plans Engineering analysis for complex design/process issues and providing rationale Verification and Validation plans and protocols.
- Experience in ECO/ECN and its related Process and PDM and PLM Tools.
- Experience of Non-Conformance Evaluation.
- Experience of working on Design History Files and Technical Files
- Work experience on obsolescence management.
- Client interaction Weekly status reports Multiple stake holder interaction
- Able to deliver independently guide juniors for project and training
Key Skills
- ASP.NET
- Health Education
- Fashion Designing
- Fiber
- Investigation
