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
- Strong 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
- Strong 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