Job Summary

Review design documentation, develop and execute verification and validation activities, maintain traceability, and support regulatory compliance for medical devices

Key Responsibilities
Support DHF remediation activities for legacy and current medical devices
Review design documentation and identify gaps against regulatory requirements
Create, update, and execute Verification Validation (VV) test protocols
Develop and maintain test cases and test procedures
Execute functional, system, regression, integration, and compatibility testing
Analyze test results and document defects
Work with development teams to resolve identified issues
Maintain complete traceability between requirements, risks, design outputs, and test evidence
Review and update DHF documentation, including Software Requirements Specifications (SRS), Software Design Descriptions (SDD), VV reports, risk management documents, and the Requirements Traceability Matrix (RTM)
Participate in design reviews and regulatory audits
Support defect management using JIRA, ALM, or similar tools




Ensure compliance with quality processes and applicable regulatory standards

Required Skills Qualifications
Strong understanding of DHF remediation activities
Hands-on experience with EU MDR remediation projects
Experience in the medical device software development lifecycle
Robust experience in verification and validation testing
Experience with requirements traceability and risk-based testing
Knowledge of EU MDR 2017/745, IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 820 / QMS
IEC 60601 knowledge is preferred
Experience with defect tracking tools such as JIRA, ALM, or Azure DevOps
Robust documentation and communication skills

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Dhf Remediation Test Engineer Eu Mdr Pune
🏢 Code Work It Solutions
📍 Pune