Systems Verification & Test Engineer II - Medical Devices
About the role
5-8 years of Experience Position Summary · Support new product development and sustaining engineering activities for Class II medical devices. Responsible for verification planning, protocol authoring, test execution, traceability, engineering investigations, and development of objective evidence supporting design controls and regulatory compliance. Key Responsibilities · Author and execute Verification Plans, Protocols, Engineering Test Reports (ETRs), Verification Reports, and Summary Reports for medical devices, sub-systems, or software/hardware components. · Maintain requirements traceability between product requirements, user inputs, design outputs, and verification evidence. · Develop system-level test strategies, test coverage assessments, and verification approaches for hardware, software, and integrated systems. · Support design control activities throughout the product lifecycle including design reviews, design changes, and DHF documentation. · Perform feasibility, characterization, reliability, regression, and design verification testing. · Design, build, validate, and maintain test fixtures, instrumentation, test setups, and custom test equipment. · Hands-on experience with test equipment such as oscilloscopes, multimeters, environmental chambers, data-acquisition systems, motion/force measurement tools, or optical/fluidic test setups. · Investigate failures, perform root-cause analysis, document anomalies, and support CAPA activities. · Design and validate test methods, fixtures, instrumentation, and automated test solutions. · Collaborate with cross-functional teams and support sustaining engineering and field-return investigations. · Ensure compliance with GMP documentation practices, Identify project risks early, track anomalies/defects. Required Qualifications & Skills · Education: Degree (B.Sc., M.Sc., or Ph.D.) in Biomedical Engineering, Mechatronics, Electrical Engineering, Computer Science, or a related technical field. · Experience: Professional experience in design verification and validation within the medical device, biotech, or combination products industry. · Standards & Regulations: Solid knowledge of ISO 13485, Design Controls (FDA 21 CFR 820), ISO 14971 (Risk Management), and IEC standards. · Technical Skills: Experience with laboratory test equipment, automation concepts, or software/hardware testing (depending on focus). · Soft Skills: Strong analytical mindset, structured way of working, problem-solving skills, and good communication skills in English (written and spoken).