Role & responsibilities

Requirement DHF remediation.

Overall exp – 4+ years

Qualification Criteria- BE/BTECH

Mandatory Skills – DHF remediation, EU MDR , medical device

ONLY IMMEDIATE JOINERS REQUIRED

Work 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 current 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

Robust 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.

Positive 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.

Education
BE/B.Tech/MCA or an equivalent technical degree.

📌 Dhf Remediation Pune
🏢 Idexcel
📍 Pune