Verification Validation Engineer

Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification \& validation, regulatory standards \& compliance requirements along with technologies such as artificial intelligence, cloud and IoT.

Tata Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified.

Job Description: Test Leader – New Product Development

Role: Test Leader / Test Manager

Experience: 10–15\+ years

Location- Pune

Role Overview

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

Key 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
• Drive automation strategy using C\+\+, Squish, and frameworks
• Lead GUI testing for Qt/QML-based applications
• Ensure traceability via JIRA
• Collaborate with R\&D, system engineering, product teams
• Drive risk-based testing for safety-critical systems
• Track quality metrics, defects, and test progress
• Support audits, design reviews, and regulatory submissions

Must-Have Skills

• Experience in medical device / regulated domain testing
• Strong hands-on in C\+\+ testing \& debugging
• Expertise in Qt/QML application testing (GUI validation)
• Experience with Squish for GUI automation
• 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

• 10–15\+ years in software testing/V\&V
• 3–5\+ years in Test Leadership roles
• Experience in new product development programs