Systems Verification Engineer

Join Smith+Nephew's dynamic Robotics Systems Test team in Pune, India, as a Systems Verification Engineer. You will play a crucial role in ensuring the safety, performance, and compliance of advanced robotic medical devices. Your responsibilities will include developing and executing comprehensive test strategies, authoring and managing test protocols, and ensuring traceability between requirements, tests, and results to support regulatory submissions (FDA, EU MDR, ISO 13485). You will also be involved in equipment planning, defect management using tools like JIRA, and contributing to Agile transformation efforts including test automation. This role requires close collaboration with cross-functional teams and a strong understanding of product development involving hardware, firmware, and software.

Key Responsibilities:

• Execute System Verification & Validation: Develop and execute test strategies and protocols for complex robotic systems.
• Documentation: Author and manage test protocols, test cases, traceability matrices, and test reports.
• Regulatory Compliance: Ensure traceability for regulatory submissions (FDA, EU MDR, ISO 13485).
• Equipment Planning: Coordinate lab resource availability for verification activities.
• Defect Management: Identify, report, track defects, validate fixes, and support root cause analysis.
• Agile & Automation: Contribute to Agile practices, test-driven development, BDD, and AI-assisted test automation.
• Collaboration: Work closely with systems, software, and hardware teams, and global stakeholders.
• Project Support: Provide input to project plans, risk registers, and design control documentation.

Qualifications:

• Education: BS, MS, or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering.
• Experience: 1-2 years of relevant experience.
• Tools: Experience with JIRA, Cockpit, Windchill, or similar requirement, test, and work management tools.
• Skills: Strong communication, problem-solving, and critical thinking skills.
• Agile Knowledge: Familiarity with SAFe, SCRUM, or related Agile frameworks.
• Technical Knowledge: Understanding of product development involving hardware, firmware, and software.
• Regulatory Knowledge: Familiarity with ISO 13485, IEC62304, and FDA QS Regulation 21 CFR Part 820.
• Physical Demands: Ability to move lab equipment.

Smith+Nephew offers a hybrid work model, educational assistance, flexible time off, comprehensive wellbeing benefits, and free cab transport. We are committed to inclusion and belonging.