Job Description

Company Overview

Tata Elxsi is among the world's leading providers of design and technology services across industries, including Automotive, Broadcast, Communications, Healthcare, and Transportation.

Tata Elxsi works with leading OEMs and suppliers in the automotive and transportation industries for R&D;, design, and product engineering services from architecture to launch and beyond.

Role Brief

Lead end-to-end Verification & Validation (V&V;) for medical device new product development, ensuring regulatory compliance and high product quality.

Roles & Responsibilities

- Lead test strategy, planning, and execution for NPD programs.
- Define V&V; approach aligned with IEC 62304, ISO 13485, FDA.
- Manage functional, system, integration, and regression testing.
- Ensure traceability via JIRA.
- Collaborate with R&D;, System Engineering, and Product teams.
- Drive risk-based testing for safety-critical systems.
- Track quality metrics, defects, and test progress.
- Support audits, design reviews, and regulatory submissions.




- Experience in new product development programs.

Must-Have Skills

- Experience in medical device / regulated domain testing.
- Solid hands-on in C++ testing & debugging.
- Proficiency in JIRA / ALM tools.
- Strong understanding of SDLC / V-Model.
- Proven test leadership and team management.
- Knowledge of IEC 62304, ISO 13485, FDA compliance.

Good-to-Have Skills

- Experience in Agile / Scrum.
- Exposure to embedded systems & HMI testing.
- Knowledge of CI/CD pipelines & automation integration.
- Familiarity with ISO 14971 risk management.

Education

- Bachelor's in Computer Science / Electronics / Biomedical / equivalent.

Experience

- 8 to 15+ years in Software Testing / Verification & Validation (V&V;).
- 3 to 5+ years in Test Leadership roles.

Skills: iec 62304 , Sdlc, medical device , Testing, Debugging, V Model, Verification Validation, Iso 13485, Llm, Scrum, Jira, Software Testing, Agile

Experience: 8.00-15.00 Years

📌 Test Leader / Test Manager | Verification & Validation (Pune)
🏢 Tata Elxsi
📍 Pune