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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Systems Test Engineer - **Company:** Actalent - **Location:** Garner, NC, United States - **Salary:** $72,800.0 - $104,000.0 - **Contract:** Temporary contract - **Skills:** Microsoft Word, Microsoft Excel, Computer-Aided Design, Microsoft Windows, Data Analysis, Systems Engineering, Automation of Tests, Batch Files, Computer Engineering, Event Logging, Python (Programming Language), MATLAB, Microsoft Office, Microsoft PowerPoint, Regression Testing, Requirements Management, Software Engineering, Software Requirements Analysis, Verification and Validation (Software), Subsystems, Systems Integration, Jama (Software), Scripting, Test Scripts, Hardware Testing, System-level Testing - **Published:** October 26, 2026 - **Apply:** https://www.techcareers.com/job.asp?id=3467471914&tx=TT4138TYV&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54 ## About the Role * 35 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, rework, or test setup support. * Ability to interpret and apply usability and human factors considerations in line with relevant standards., * Experience with X-ray or other radiological medical devices, including system-level testing and safety considerations. * Familiarity with developing test tools, fixtures, and methods for system verification and automation. * Knowledge of IEC standards for medical electrical equipment, including requirements related to hardwarefirmwaresoftware interface designs. * Experience with requirements management tools such as JAMA or DOORS for traceability and documentation. * Proficiency in Python or MATLAB for test automation, data acquisition, and data analysis. * Experience using CAD modeling tools to support test fixture design, system understanding, or documentation. * Introduced to intermediate soldering capability for assembling or modifying test setups and prototypes. * Experience with medical device usability and human factors standards such as AAMI/FDA HE75. * Familiarity with system-level risk management processes, including hazard analysis and risk control implementation. * Ability to work effectively in cross-functional R&D teams and communicate clearly with engineering, quality, and regulatory stakeholders. ## Description 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., * 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., You will work in a laboratory-based R&D environment focused on medical X-ray devices and other complex electro-mechanical medical systems. The role involves frequent use of electronic test equipment such as oscilloscopes, specialized medical device test tools, and standard lab instruments. You will work primarily on Windows-based systems, using tools such as MS Office, requirements management platforms like JAMA or DOORS, and scripting or analysis environments in Python or MATLAB. The position requires hands-on interaction with hardware, including test setups, prototypes, and fixtures, as well as occasional CAD review and light soldering work. Work is typically conducted during standard business hours, with collaboration across engineering, quality, and regulatory teams in a structured, process-driven environment that emphasizes regulatory compliance, detailed documentation, and safe operation around radiological equipment.