Job Summary
We are seeking a Software Test Engineer to perform Verification & Validation (V&V;) activities for medical device software, ensuring product quality, safety, and compliance in a regulated environment. The role involves requirements-based testing, hands-on device testing (hardware–software integration), defect management, and producing audit-ready test evidence.

Job Title - Software V&V; Testing – (Medical : Verification & Validation)
Location: Pune

Key Responsibilities
Develop and execute test plans, test cases, and validation protocols based on system and software requirements.
Ensure complete Requirement Traceability (RTM) between system requirements, test cases, and defects.
Designed and executed test plans, test cases, and validation protocols aligned with IEC 62304 and ISO 13485 standards.
Supported risk-based testing aligned with ISO 14971 (FMEA, hazard analysis).
Logged and tracked defects using JIRA/ALM, including detailed root cause analysis (RCA).
Collaborated with cross-functional teams (HW, FW, QA, RA) for design reviews and issue resolution.




Validate real-time behavior and ensure deterministic system responses.
Prepared V&V; documentation for regulatory audits (FDA/CE readiness).

Required Educational Qualification:
MTech / ME / BE / BTech in Biomedical, Electrical, Software, Electronics or Systems Engineering.
3–8 years of experience in Software V&V; for medical devices.
Strong understanding of design controls, risk management, and regulatory frameworks.
Experience with test development, execution, and documentation in a regulated setting.
Strong analytical, documentation, and communication skills.

Required Technical Skills:
Test case design techniques (boundary, equivalence, state-based testing)
Familiarity with:
Automation scripting (Python preferred)

Required Tools:
Test Management & Tracking:
JIRA / ALM / Putty / DOORS
Automation & Scripting:
Python / MATLAB
Debugging & Analysis:
Serial logs
Logic analyzers

Medical Standards (Worki

📌 Software V&V Testing (India)
🏢 Tata Elxsi
📍 India