DHF, MDR remediation test engineer

LTTS · Pune

Source and collection record

Last observed by our collector: 8 October 2026 at 11:41 pm IST. This is not a manual review or a confirmation from the employer.

Employer requisition: 531679

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Collected role description

4+ Years Location : Pune Job Summary We are looking for a skilled Test Engineer with experience in Design History File (DHF) remediation and EU MDR (Medical Device Regulation) compliance. The candidate will support remediation activities by reviewing design documentation, creating/updating verification and validation evidence, executing test cases, and ensuring compliance with regulatory standards throughout the product lifecycle. Roles & Responsibilities Support DHF remediation activities for legacy and new medical devices. Review design documentation to identify gaps against regulatory requirements. Create, update, and execute verification and validation (V&V) test protocols. Develop and maintain test cases, test procedures, and traceability matrices. Execute functional, system, regression, integration, and compatibility testing. Analyze test results, document defects, and work with development teams for resolution. Ensure complete traceability between requirements, risks, design outputs, and test evidence. Review and update DHF documents such as: Software Requirements Specification (SRS) Software Design Description (SDD) Verification & Validation reports Risk Management documents Traceability Matrix (RTM) Participate in design reviews and regulatory audits. Support defect management using tools such as Jira or ALM. Ensure compliance with company quality processes and regulatory standards. Required Skills Strong understanding of DHF remediation activities. Hands-on experience in EU MDR remediation projects. Knowledge of medical device software development lifecycle (SDLC). Experience in verification and validation testing. Good understanding of: IEC 62304 ISO 14971 IEC 60601 (preferred) ISO 13485 FDA 21 CFR Part 820 / QMS EU MDR 2017/745 Experience in requirements traceability and risk-based testing. Knowledge of defect tracking tools (Jira, ALM, Azure DevOps). Excellent documentation and communication skills.

Collected experience requirement

4+ years