V&V; Engineer – DHF Remediation

Location: Pune

Experience: 4–9 Years

Domain: Medical Devices

Qualification: B.E./B.Tech/M.E./M.Tech/M.Sc./M.Pharm

Notice Period: Immediate to 30 Days

Role Overview

We are looking for an experienced V&V; Engineer with solid expertise in Design History File (DHF) Remediation, Design Controls, and Verification & Validation documentation in the medical device domain. The candidate will be responsible for reviewing, updating, and remediating design documentation to ensure compliance with medical device regulatory requirements.

Key Responsibilities
Review and perform gap assessments of existing Design History Files (DHF).
Remediate design control documents, including user needs, design inputs, design outputs, and design review records.
Prepare and review verification protocols, test reports, validation reports, and traceability matrices.
Perform medical device verification testing and prepare verification documentation.
Ensure traceability between user needs, design requirements, risk controls, and verification/validation evidence.




Conduct root cause analysis and support remediation closure activities.
Support risk management documentation, including hazard analysis, DFMEA, and risk assessment reports.
Assist with technical file remediation and regulatory documentation updates.
Collaborate with R&D;, Quality, Regulatory Affairs, and other cross-functional teams.

Mandatory Skills
DHF Remediation and Design Controls.
Verification & Validation (V&V;).
Medical Device Testing.
Protocol Drafting and Verification Reporting.
Technical Documentation Review.
Requirements Traceability.
Root Cause Analysis.
Medical Device Product Development Lifecycle.

Regulatory Knowledge

Working knowledge of the following standards and regulations:
EU MDR 2017/745.
ISO 13485:2016.
ISO 14971.
FDA 21 CFR Part 820 / QMSR.
IEC 62366 and IEC 60601 series.

Basic understanding of medical device risk management is required.

Valuable to Have: Experience with Windchill PLM, Agile PLM, Teamcenter, TrackWise, and Microsoft Office Suite.

📌 V&v Engineer – Dhf Remediation Pune
🏢 CSbusinesmgmt.in
📍 Pune