System Test Engineer - Med Devices

System Test Engineer - Med Devices

As a System Test Engineer, you will play a key role in validating both cloud-based web applications and advanced robotic surgical platform devices. This position involves end-to-end system testing, ensuring that system and subsystem requirements are thoroughly verified. You will be responsible for producing essential Design History File (DHF) deliverables, including detailed test procedures and comprehensive test reports. Collaboration is central to this role—you'll work closely with cross-functional engineering teams to design and implement robust, effective test strategies that support product quality and reliability.

Your role:

• Execute System Verification & Validation: participate in developing and executing comprehensive test strategies for complex robotic systems, ensuring alignment with product requirements and regulatory standards.
• Participate in authoring and managing verification plans, protocols, test cases, traceability matrices, and summary reports.
• Traceability: ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
• 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.
• 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.

Your skills and experience:

• BS, MS, or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering
• 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
• Experience in Test Automation using scripting language like Python.

Life at Capgemini:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini Engineering:

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries.

Disclaimer: Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.