Systems Test Engineer

Systems Verification & Validation Engineer, R&D (Medical Devices)

This role focuses on leading verification and validation activities for medical X-ray devices within a regulated R&D environment. You will design and execute comprehensive system-level tests for hardware, software, and mechanical components, ensuring compliance with medical device regulations and industry standards. Working closely with cross-functional teams, you will help deliver safe, effective, and high-quality products through rigorous testing, documentation, and risk management.

Responsibilities

• Design, develop, and execute comprehensive test plans to verify the functionality, performance, and safety of medical device systems, including hardware, software, and mechanical components.
• Analyze system requirements and take ownership of verification and validation activities, ensuring compliance with applicable FDA and ISO standards.
• Collaborate with cross-functional teams such as software development, hardware engineering, and quality assurance to drive successful verification of product performance.
• Conduct systems engineering testing for complex hardware and software in laboratory environments using appropriate testing tools, equipment, and methodologies.
• Develop system-level integration and regression test scenarios, as well as protocols for functional testing of Class II medical devices.
• Identify, analyze, and document test results, defects, and non-conformities, and work closely with development teams to troubleshoot and resolve issues.
• Develop, maintain, and update detailed documentation for test protocols, test cases, and test reports throughout the product lifecycle.
• Ensure compliance with relevant medical device industry regulations and standards, including FDA submissions and applicable ISO, IEC, and AAMI/FDA usability standards.
• Participate in risk management activities, including hazard identification, risk analysis, and risk mitigation, ensuring risks are effectively managed across the system.
• Contribute to product risk management strategies, usability considerations, and regulatory compliance in collaboration with engineering, quality, and regulatory teams.
• Streamline development and V&V activities, monitor technical milestones, and ensure that verification and validation objectives are achieved within project timelines.
• Review system-level requirements and help define and refine sub-system requirements to ensure testability and traceability.
• Support the development of test tools and methods for system verification, including automation and custom fixtures where appropriate.

Essential Skills

• 3–5 years of experience in medical device verification and validation within a regulated industry such as healthcare or aerospace.
• Direct experience in systems-level verification and validation within the medical device industry, preferably with electro-mechanical devices.
• Strong familiarity with medical device industry standards and regulatory frameworks, including FDA submissions (such as 510(k)) and relevant ISO and IEC standards.
• Proven experience in writing and executing system-level verification and validation protocols for complex systems.
• Ability to review system-level requirements and define or refine sub-system requirements to support robust testing.
• Hands-on experience with medical device testing, ensuring compliance with applicable regulations and industry standards.
• Experience understanding, creating, and updating engineering drawings and electrical or electronic schematics.
• Experience with validation and hardware test activities, including use of common test equipment.
• Ability to perform system-level testing and verification in laboratory environments.
• Proficiency in using oscilloscopes and other electronic test instruments.
• Familiarity with the Windows operating system, including IT troubleshooting, working with Windows event logs, and creating batch files or task automations.
• Proficiency with MS Office tools, including Word, PowerPoint, and Excel, for documentation, reporting, and analysis.
• Experience working with medical devices, including X-ray or other radiological systems.
• Basic to intermediate soldering skills for prototyping,…