Key Responsibilities

Develop and execute Verification & Validation plans, protocols, and test cases based on system and product requirements.

Perform manual and automated testing of embedded systems, software, and integrated hardware platforms.

Collaborate with cross-functional teams (Software, Hardware, Systems, Program) to define V&V plans, protocols, and traceability matrices.

Design and implement test cases and procedures based on system requirements and risk analysis.

Manage test environments, including hardware/software setups, simulators, and lab equipment.

Ensure compliance with FDA and ISO 13485 standards.

Analyze test results, identify defects, and drive root cause analysis and corrective actions.

Prepare and maintain V&V documentation for design reviews, audits, and regulatory submissions.

Required Qualifications

3.5-5yrs experience in manual testing (proficiency) and familiarity with test automation scripting should be good enough.

Bachelors or Masters degree in Biomedical Engineering, Electrical Engineering, Computer Science, or related field.

Minimum 7 years of hands-on experience in medical device V&V, including system-level testing.

Strong understanding of impact analysis, design controls and medical device quality process.

Proficiency in test automation tools, scripting languages (Python, LabVIEW, etc.), and defect tracking systems.

Familiarity with embedded systems, firmware, and software-hardware integration.

Excellent communication, documentation, and team lead skills.

Preferred Skills

Good analytical skills, Self driven with least supervision and taking ownership on deliverables.

Familiarity with Regression, Non-functional testing and usability engineering in medical devices.

Certifications such as ASQ Certified Quality Engineer (CQE) or ISTQB are a plus.

System Tester