Role 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 solid 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 -

4 to 9 years of experience in medical device product development, quality engineering, design assurance, or DHF remediation.
DHF Remediation
Design Controls
Technical Documentation Review
Requirements Traceability
Verification & Validation Documentation
Root Cause Analysis
Medical Device Product Development Lifecycle
Hands-on experience supporting EU MDR remediation programs.
Proven expertise in traceability reconstruction, risk file updates, and remediation of Design Control documentation.
Experience supporting Class II/Class III medical devices is strongly preferred.

📌 Remediation Engineer Pune
🏢 Larsen and Toubro (L&T)
📍 Pune