Verification And Validation Lead (Medical Devices)

Job description

**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 (hardwaresoftware integration), defect management, and producing audit-ready test evidence. **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 environment. Strong analytical, documentation, and communication skills. **Required Technical Skills:** Test case design techniques (boundary, equivalence, state-based testing) - **Familiarity with:** Automation scripting (Python preferred) **Languages required:** **Required Tools:** Test Management & Tracking: JIRA / ALM / Putty / DOORS Automation & Scripting: Python / MATLAB Debugging & Analysis: Serial logs Logic analyzers **Medical Standards (Working Knowledge Required)** IEC 62304 – software lifecycle for medical devices ISO 13485 – quality management system ISO 14971 – risk management (hazards, risk controls testing) IEC 60601 – safety and essential performance basics **Key Deliverables** Verified and validated software releases Complete test documentation with traceability Defect reports and closure evidence Compliance-ready audit documentation