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

Regression Testing Industry Standards Systems Engineering System Requirements Microsoft PowerPoint Software Development Computer Engineering Engineering Drawings Electrical Equipment Regulatory Compliance Regulatory Frameworks Artificial Intelligence Requirements Management Electronic Test Equipment Engineering Design Process Process Driven Development Verification And Validation Python (Programming Language) Milestones (Project Management) Troubleshooting (Problem Solving), 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.

Scripting Usability Soldering Visionary Leadership Automation Innovation Test Tools Prototyping Testability Batch Files Risk Control Traceability Oscilloscope Communication Test Planning Risk Analysis Human Factors IEC Standards Fixture Design Microsoft Excel Risk Mitigation Risk Management Test Automation Medical Devices Hazard Analysis Microsoft Office Data Acquisition Electromechanics Quality Assurance ISO/IEC Standards, * 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, 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 hardware-firmware-software 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.

Work Environment

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. Job Type & Location, Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors., Garner, NC, *On-Site

MATLAB Scripting Usability Soldering Visionary Leadership Automation Innovation Test Tools Prototyping Testability Batch Files Risk Control Traceability Oscilloscope Communication Test Planning Risk Analysis Human Factors IEC Standards Fixture Design Microsoft Excel Risk Mitigation Risk Management Test Automation Medical Devices Hazard Analysis Microsoft Office Data Acquisition Electromechanics Quality Assurance ISO/IEC Standards Functional Testing Regression Testing Industry Standards Systems Engineering System Requirements Microsoft PowerPoint Software Development Computer Engineering Engineering Drawings Electrical Equipment Regulatory Compliance Regulatory Frameworks Artificial Intelligence Requirements Management Electronic Test Equipment Engineering Design Process Process Driven Development Verification And Validation Python (Programming Language) Milestones (Project Management) Troubleshooting (Problem Solving) +0

Google IT Automation with Python Systems Test Engineer Actalent

Garner, NC*On-Site

MATLAB Scripting Usability Soldering Visionary Leadership Automation Innovation Test Tools Prototyping Testability Batch Files Risk Control Traceability Oscilloscope Communication Test Planning Risk Analysis Human Factors IEC Standards Fixture Design Microsoft Excel Risk Mitigation Risk Management Test Automation Medical Devices Hazard Analysis Microsoft Office Data Acquisition Electromechanics Quality Assurance ISO/IEC Standards Functional Testing Regression Testing Industry Standards Systems Engineering System Requirements Microsoft PowerPoint Software Development Computer Engineering Engineering Drawings Electrical Equipment Regulatory Compliance Regulatory Frameworks Artificial Intelligence Requirements Management Electronic Test Equipment Engineering Design Process Process Driven Development Verification And Validation Python (Programming Language) Milestones (Project Management) Troubleshooting (Problem Solving) +0

Google IT Automation with Python

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.