V&V with DHF Remediation (Contract)
Job Summary
The DHF Remediation Engineer will be responsible for reviewing assessing remediating and updating Design History Files (DHF) and Design Control documentation for medical devices to ensure compliance with EU MDR 2017/745 ISO 13485 ISO 14971 and FDA Design Control requirements. The role requires strong expertise in design controls risk management traceability verification and validation documentation technical file remediation and cross-functional collaboration with R&D Regulatory Affairs Quality and Clinical teams.
Mandatory Skills -
- DHF Remediation
- Design Controls
- Technical Documentation Review
- Requirements Traceability
- Verification & Validation Documentation
- Root Cause Analysis
- Medical Device Product Development Lifecycle