Senior Systems Verification Engineer

Senior Systems Verification Engineer

Location: Kharadi, Pune

At Smith+Nephew, we design and manufacture technology that takes the limits off living.

Join our dynamic Robotics Systems Verification team where cutting-edge technology meets rigorous verification. As a Senior Systems Verification Engineer, you will play a pivotal role in ensuring the safety, performance, and compliance of advanced robotic medical devices that integrate hardware, software, firmware, and cloud services.

What will you be doing?

• Lead System Verification & Validation: Develop and execute comprehensive test strategies for complex robotic systems, ensuring alignment with product requirements and regulatory standards.
• Traceability: Ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
• Test Planning & Execution: Author and manage verification plans, protocols, test cases, traceability matrices, and summary reports.
• Equipment Planning: Coordinate with lab management to ensure adequate resources (equipment, personnel, lab space) are available to meet verification timelines.
• Defect Management: Identify, report, and track hardware/software defects using tools like JIRA; validate fixes and support root cause analysis. Track defects through lifecycle to closure.
• Agile & Automation Practices: Contribute to Agile transformation efforts, including test-driven development, BDD, AI-assisted test automation, and backlog management.
• Cross-Functional Collaboration: Work closely with systems engineers, software and hardware teams, and global stakeholders to ensure seamless integration and testing.
• Regulatory Compliance: Ensure traceability between requirements, test protocols, and results to support FDA, EU MDR, and ISO 13485 submissions.
• Project Support: Provide input to technical project plans, risk registers, and design control documentation. Participate in design reviews and FMEAs.
• Performance Tracking: Define and monitor KPIs such as test coverage, defect density, on-time sprint delivery, and verification cycle time to drive continuous improvement.

What will you need to be successful?

• Education: BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering. Prefer MS or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, Biomedical Engineering
• Experience: 6+ years of experience in delivering medical device solutions to production with a BS degree (3+ years with a MS degree). 3+ years of experience in medical device verification & validation testing.
• Tools Experience: Jira, Cockpit, Windchill, or other requirements management, test management, and work management tools.
• Outstanding communication, facilitation, and coaching skills
• Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks and methodologies
• Understanding of the application of ISO 13485, IEC62304 and FDA QS Regulation 21 CFR Part 820
• Experience with product development involving hardware, firmware, and software elements
• Experience presenting to executive level management on project status.
• Physical Demands: Moving lab equipment and systems under test around in lab spaces.

We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about Employee Inclusion Groups on our website.

Other reasons why you will love it here!

• Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance.
• Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave.
• Your Wellbeing: Parents/Parents-in-Law's Insurance (Employee Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave.
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.