DHF Remediation Engineer

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 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

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.