System Test Engineer - Med Devices at Capgemini Portugal

Pittsburgh, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

0.0

Posted On

25 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

System Testing, Verification And Validation, Agile Methodologies, Test Automation, Defect Management, Regulatory Compliance, Cross-Functional Collaboration, Communication Skills, Requirements Management, Test Procedures, Design History File, Root Cause Analysis, Performance Tracking, Traceability, Project Support, Scripting Languages

Industry

IT Services and IT Consulting

Description

About the job you’re considering 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 Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer: 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 has 65,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet. 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. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion. Get the future you want | www.capgemini.com 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. This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship. Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact. Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process. Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.

Responsibilities

As a System Test Engineer, you will validate cloud-based web applications and robotic surgical platform devices through end-to-end system testing. You will collaborate with engineering teams to design and implement effective test strategies that ensure product quality and reliability.