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