Software V&V Testing

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 (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 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) 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