About the role
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.