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 -
DHF Remediation
Design Controls
Technical Documentation Review
Requirements Traceability
Verification & Validation Documentation
Root Cause Analysis
Medical Device Product Development Lifecycle

Key Responsibilities

DHF Assessment & Remediation
Perform detailed gap assessments of legacy and active DHF documentation.
Review and remediate:
User Needs
Intended Use Statements
Product Requirements
Design Inputs
Design Outputs
Design Review Records
Design Verification Reports




Design Validation Reports
Design Transfer Documentation
Traceability Matrices
Ensure completeness and consistency of design control records across the product lifecycle.

Design Control Activities
Support remediation activities in accordance with Design Control requirements.
Ensure traceability between:
User Needs
Design Inputs
Design Outputs
Risk Controls
Verification Evidence
Validation Evidence
Support design review meetings and remediation closure activities
4 to 12 years of experience in medical device product development, quality engineering, design assurance, or DHF remediation.
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.

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