System Tester

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.

· Bachelor’s or Master’s 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.