Software V&V Testing

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