Medical Device (System V&V) Engineer Systems Ally Irvine, CA Job Details Contract $40 - $75 an hour 4 hours ago Qualifications Jira Teamwork TestNG Content creation for technical audiences Test Case Documentation (Quality assurance practices) Technical documentation Selenium Quality risk management JavaScript System requirements definition Design controls Technical troubleshooting support Technical writing experience within technology Cross-functional communication Test Planning (Quality assurance practices) Full Job Description We are looking experienced System Verification Engineers to support the verification and validation of complex medical devices, combination products, electromechanical systems, and Software as a Medical Device (SaMD) . The ideal candidate has strong hands-on experience developing and executing system-level verification and test activities for regulated medical products. This includes translating system and product requirements into comprehensive verification strategies, test methods, protocols, and reports, executing testing, analyzing results, and working cross-functionally to resolve failures and design issues. This is a hands-on engineering role , not primarily a documentation or test-management position. The successful candidate will work closely with Systems Engineering, R D, Software/Firmware, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Clinical/Usability teams throughout the product development lifecycle. The role may support products ranging from Class I through Class III medical devices , including electromechanical devices, connected/IoT devices, combination products, and software-based medical products. Key Responsibilities Develop and execute system verification and validation (V&V) strategies for medical devices and combination products. Translate system requirements, user needs, design inputs, and product specifications into comprehensive verification plans and test cases. Develop system-level test methods, test protocols, test procedures, acceptance criteria, and verification reports . Perform hands-on testing of complex medical device systems, including functional, performance, safety, reliability, environmental, and interface testing. Develop requirements-to-test traceability and ensure complete verification coverage of system and subsystem requirements. Perform requirements analysis to identify ambiguity, gaps, conflicts, and requirements that are difficult or impossible to verify. Work with Systems Engineering and R D to define objective, measurable, and testable requirements . Develop test fixtures, test setups, instrumentation, simulators, and test environments as needed. Execute manual and automated test procedures and document objective evidence in accordance with applicable procedures and Quality System requirements. Analyze test results, identify anomalies, troubleshoot failures, and support root-cause investigations. Lead or support verification failure investigations , including determination of test error versus product/design failure. Collaborate with design engineers to identify corrective actions and perform appropriate regression testing. Support verification of hardware, firmware, software, mechanical, electrical, and system-level functionality . Support testing of device interfaces, communications, connectivity, sensors, actuators, alarms, displays, user interfaces, and system controls, as applicable. Support integration testing across hardware, software, firmware, and mechanical subsystems. Participate in design reviews and provide verification/testability feedback throughout the product development lifecycle. Support Design Verification (DV) and, where applicable, Design Validation (PV) activities. Support development of verification strategies based on product risk, intended use, and applicable regulatory requirements. Work closely with Risk Management teams to ensure verification activities adequately address risk control measures and safety-related requirements . Provide objective evidence demonstrating that risk controls have been appropriately verified. Support Design FMEA, System FMEA, Fault Tree Analysis (FTA), and other risk-management activities as applicable. Ensure verification activities are appropriately linked to requirements, risk controls, and design outputs. Support Design History File (DHF) documentation and maintain accurate, complete, and traceable verification records. Support protocol/report reviews and ensure deviations, anomalies, and test exceptions are appropriately documented and resolved. Work with Quality and Regulatory teams to ensure verification activities meet applicable regulatory and quality-system expectations. Support product changes, design changes, sustaining engineering, and regression testing. Participate in technical investigations, CAPA, nonconformance, complaint, and post-market activities when verification expertise is required. Communicate verification status, test results, risks, issues, and recommendations to technical and project leadership. Product Experience Experience with one or more of the following is highly valuable: Electromechanical medical devices Drug-delivery devices Combination products On-body delivery systems Infusion pumps Autoinjectors and wearable injectors Pre-filled syringe systems Connected/IoT medical devices Patient monitoring systems Diagnostic devices Surgical or therapeutic devices Automated medical devices Medical device software SaMD Embedded systems Devices containing hardware, firmware, and software interfaces Required Qualifications Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering , or a related technical discipline. 3+ years of hands-on verification/testing experience in medical devices, combination products, diagnostics, regulated products, aerospace, automotive, or another highly regulated industry. Strong experience with system-level verification and test engineering . Experience developing and executing verification protocols, test procedures, and test reports. Strong understanding of requirements-based verification and traceability . Experience converting requirements into testable verification methods and objective acceptance criteria. Experience troubleshooting test failures and working with engineering teams to resolve technical issues. Experience working within a formal Quality Management System and Design Control environment . Experience with risk-based verification and verification of risk controls. Strong technical writing and documentation skills. Excellent analytical, problem-solving, communication, and cross-functional collaboration skills. Preferred Qualifications Master's degree in Engineering, Biomedical Engineering, Systems Engineering, Computer Science, or related field. Experience with Class II or Class III medical devices and/or combination products. Experience with FDA Design Controls and 21 CFR Part 820/QMSR . Working knowledge of ISO 13485 and

ISO 14971

. Experience with

IEC 62304

for medical device software. Experience with IEC 60601 and medical electrical equipment. Experience with

IEC 62366

usability engineering. Experience with cybersecurity verification for connected medical devices. Experience with software/firmware verification and validation. Experience with automated test frameworks and scripting using Python, MATLAB, LabVIEW, C/C++, or similar tools . Experience with hardware-in-the-loop (HIL), software-in-the-loop (SIL), simulation, emulation, or automated testing. Experience using requirements and test-management tools such as Jama, Polarion, IBM DOORS, Azure DevOps, Jira, or similar platforms . Experience with statistical analysis, Design of Experiments (DOE), reliability testing, or data analysis. Experience developing test fixtures and using laboratory instrumentation such as oscilloscopes, multimeters, power supplies, data acquisition systems, pressure/force sensors, temperature sensors, and other measurement equipment. Key Technical Skills System Verification | System Testing | V&V | Design Verification | Requirements Verification | Test Method Development | Test Protocols | Test Procedures | Verification Reports | Requirements Traceability | Risk Management |

ISO 14971

| Design Controls | DHF |

FDA 21 CFR

Part 820/QMSR |

ISO 13485

| Medical Devices | Combination Products | Electromechanical Systems | Embedded Systems | Firmware | Software | SaMD | Test Automation | Root Cause Analysis | Failure Investigation |

Regression Testing Pay:

$40.00 - $75.00 per hour

Work Location:

In person