Job Description Medical Device V&V; Engineer

Job Title: Medical Device V&V; Engineer / Specialist
Department: Verification & Validation (V&V;)
Industry: Medical Devices / Healthcare
Experience: 6+ Years
Location: Pune
Employment Type: Full-Time

Job Summary

We are looking for an experienced Medical Device Verification & Validation (V&V;) professional with strong expertise in Design Controls, DHF remediation, verification/validation activities, requirements traceability, risk management, and regulatory documentation.

The candidate will be responsible for supporting and executing V&V; activities throughout the medical device product lifecycle, ensuring that products meet defined requirements, intended use, safety, performance, and applicable regulatory and quality standards.

The ideal candidate should have hands-on experience working with Design History Files (DHF), identifying documentation gaps, performing remediation activities, and maintaining compliance with medical device quality and regulatory requirements.

Key Responsibilities

1. Verification & Validation

- Plan, execute, and document Verification and Validation activities for medical devices.
- Develop and review V&V; strategies, protocols, test procedures, and reports.
- Define appropriate verification methods based on product requirements and risk.
- Review test results and identify deviations, failures, and non-conformances.
- Support investigation and resolution of V&V; failures.
- Ensure verification activities demonstrate that design outputs meet specified design input requirements.
- Support validation activities to demonstrate that the medical device meets its intended use and user needs.
- Participate in design reviews and product lifecycle activities.

2. DHF Management & Remediation

- Review existing Design History Files (DHF) and identify missing, incomplete, or inconsistent documentation.
- Perform DHF remediation activities based on internal quality procedures and regulatory requirements.
- Ensure appropriate documentation of:
- Design Inputs
- Design Outputs
- Design Reviews
- Design Verification
- Design Validation
- Risk Management
- Traceability
- Design Changes
- Test Reports
- Engineering documentation

- Identify gaps between design requirements, test evidence, and final product documentation.
- Establish and maintain Requirements Traceability Matrix (RTM).
- Ensure complete traceability from User Needs Design Inputs Design Outputs Verification Validation.
- Support audit readiness by ensuring DHF documentation is complete, accurate, and traceable.

3. Design Controls

- Work closely with Engineering, R&D;, Quality, Regulatory Affairs, Manufacturing,



and Product teams.
- Support implementation and maintenance of Medical Device Design Controls.
- Review design input and output documentation for completeness and consistency.
- Participate in design review meetings and document review outcomes.
- Ensure design changes are appropriately assessed and verified/validated before implementation.
- Support engineering change orders/change requests and associated V&V; activities.

4. Risk Management

- Support product risk management activities in accordance with applicable medical device standards.
- Review and maintain risk documentation and traceability.
- Support FMEA / DFMEA / hazard analysis / risk analysis activities as applicable.
- Ensure identified risks are appropriately addressed through design controls and V&V; activities.
- Establish traceability between risks, requirements, mitigations, and verification evidence.

5. Regulatory & Quality Compliance

- Ensure V&V; documentation complies with applicable medical device quality and regulatory requirements.
- Work with Quality and Regulatory teams during internal and external audits.
- Support remediation of observations related to design controls, V&V;, and DHF.
- Prepare documentation and objective evidence required for audits and regulatory submissions.
- Ensure V&V; records follow applicable SOPs, procedures, templates, and document-control requirements.

6. Test Planning & Documentation

- Create and review:
- Verification Plans
- Validation Plans
- Test Protocols
- Test Procedures
- Test Cases
- Test Reports
- Validation Reports
- Traceability Matrices
- Deviation Reports

- Review test evidence for completeness and compliance.
- Ensure test equipment, methods, acceptance criteria, and test environments are appropriately documented.
- Coordinate with test laboratories and cross-functional engineering teams when required.

7. Cross-Functional Collaboration

- Collaborate with R&D;, Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Quality, Regulatory, Manufacturing, and Clinical/User teams.
- Coordinate V&V; activities across multiple product development projects.
- Track V&V; deliverables, schedules, risks, and dependencies.
- Communicate project status, issues, and risks to stakeholders.

Required Skills





- Medical Device Verification & Validation
- Design Controls
- Design History File (DHF)
- DHF Remediation
- Requirements Management
- Requirements Traceability Matrix (RTM)
- Verification Protocols & Reports
- Validation Protocols & Reports
- Test Planning and Execution
- Risk Management
- Design Reviews
- Change Management
- CAPA / Non-Conformance awareness
- Root Cause Analysis
- Technical Documentation
- Audit Readiness

Medical Device Standards – Preferred Knowledge

- ISO 13485 – Medical Device Quality Management Systems
- ISO 14971 – Medical Device Risk Management
- IEC 62304 – Medical Device Software Lifecycle, where applicable
- IEC 60601 – Medical Electrical Equipment, where applicable
- FDA 21 CFR Part 820 / QMSR knowledge
- FDA Design Control requirements
- Design Controls and regulatory submission documentation

Preferred Experience

- Experience working in Medical Device / Healthcare product development.
- Hands-on experience with DHF remediation projects.
- Experience reviewing historical product/design documentation and identifying gaps.
- Experience creating or reviewing V&V; protocols and reports.
- Experience with requirements traceability and design-control documentation.
- Experience supporting regulatory or quality audits.
- Experience working in a regulated product-development environment.
- Knowledge of FDA / EU MDR requirements is an added advantage.

Educational Qualification

- Bachelor's or Master's degree in:
- Mechanical Engineering
- Electrical/Electronics Engineering
- Biomedical Engineering
- Electronics & Communication Engineering
- Instrumentation Engineering
- Computer Science / Software Engineering
- or a related engineering discipline.

Key Competencies

- Strong analytical and problem-solving skills
- Excellent technical documentation skills
- Robust understanding of medical device product lifecycle
- Attention to detail
- Ability to identify documentation and compliance gaps
- Good communication and stakeholder-management skills
- Ability to work independently as well as with cross-functional teams
- Strong understanding of traceability and evidence-based verification

Keywords for Recruitment

Medical Device V&V;, Verification and Validation, V&V; Engineer, V&V; Specialist, Design Controls, DHF, DHF Remediation, Design History File, Requirements Traceability, RTM, Verification Protocol, Validation Protocol, Verification Report, Validation Report, Risk Management, ISO 13485, ISO 14971, FDA 21 CFR 820, IEC 62304, IEC 60601, Design Review, Medical Device Testing, Product Validation, Regulatory Compliance, Quality Engineering.

📌 Hiring For Verification And Validation (Mysuru)
🏢 Glauben Technologies
📍 Mysuru