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Job details:
Test Engineer – DHF Remediation
Company: L&T Technology
Location: Pune
Experience: 4+ Years
Qualification: BE/B.Tech/MCA or equivalent technical degree
Open Positions: 1
Notice Period: Immediate to 15 Days
Job Summary
L&T Technology is seeking a Test Engineer with hands-on experience in Design History File (DHF) Remediation and EU MDR compliance for Medical Device projects. The ideal candidate will support remediation activities by reviewing design documentation, preparing verification and validation evidence, executing test cases, and ensuring compliance with global medical device regulations throughout the product lifecycle.
Key ResponsibilitiesDHF Remediation
- Support DHF remediation activities for legacy and new medical device products.
- Review design documentation to identify compliance gaps against regulatory requirements.
- Update and maintain Design History File (DHF) documentation.
Verification & Validation
- Create, update, and execute Verification & Validation (V&V) test protocols.
- Develop test cases, test procedures, and Requirements Traceability Matrix (RTM).
- Perform Functional, System, Integration, Regression, and Compatibility testing.
- Analyze test results, log defects, and coordinate issue resolution with development teams.
Documentation & Compliance
- Review and update:
- Software Requirements Specification (SRS)
- Software Design Description (SDD)
- Verification & Validation Reports
- Risk Management Documents
- Requirements Traceability Matrix (RTM)
- Ensure complete traceability between requirements, risks, design outputs, and verification evidence.
- Participate in design reviews and regulatory audits.
- Support defect tracking using Jira, ALM, or Azure DevOps.
Mandatory Skills
- 4+ years of experience in Software Testing within the Medical Device domain.
- Hands-on experience in DHF Remediation projects.
- Strong knowledge of EU MDR (2017/745).
- Experience in Verification & Validation (V&V) testing.
- Knowledge of Medical Device Software Development Lifecycle (SDLC).
- Experience with Requirements Traceability and Risk-Based Testing.
- Familiarity with defect management tools such as Jira, ALM, or Azure DevOps.
- Excellent documentation and communication skills.
Regulatory Knowledge
- IEC 62304
- ISO 14971
- ISO 13485
- FDA 21 CFR Part 820
- EU MDR 2017/745
- IEC 60601 (Preferred)
Preferred Skills
- Experience supporting regulatory audits.
- Strong analytical and problem-solving skills.
- Ability to work in a regulated medical device environment.
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