- Design History File (DHF) and Risk Management File (RMF) remediation.
- Medical Device Design Controls and Design Documentation.
- Traceability of User Needs, Design Inputs/Outputs, and V&V; Evidence.
- Design Verification & Validation (DV/V).
- Risk Management and Quality/Regulatory Compliance.
- ASME GD&T; and Medical Device Manufacturing Processes.
- Cognition Cockpit (Electronic DHF System).
- Knowledge of FDA and Global Medical Device Regulations.
- Minitab, Statistics and Design for Six Sigma (DFSS) are desirable.
Education & Experience:
- Bachelor's degree in Mechanical, Biomedical, Aerospace or a related Engineering discipline.
- 3–5 years of relevant engineering experience.
- Prior experience in medical device design controls and DHF/RMF remediation preferred
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📌 Design Quality Engineer (India)
🏢 The Recruiters
📍 India
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