Systems Verification Engineer II

Smith and Nephew is seeking an R&D Systems Verification Engineer II in the Sports Medicine business to drive and lead system verification efforts in partnership with the Systems Engineering and R&D New Product Development (NPD) teams. The role will work with the R&D Manager of Systems Verification. Responsibilities: Support small to medium scale projects’ test activities, allocate test equipment and materials and align with Program Management and Cross-Functional on deliverables and timeline Identify, report, track, prioritize HW/SW defects using defects management systems (e.g. JIRA) and validate fixes Support the Systems engineers with definition of new products – implementing operational profiles, preparing for test, dry-run, executing test, tracing requirements to test cases and guiding the test strategy Support trouble shooting and root causing of Systems defects and enable R&D team identify fixes Draft verification plans, protocols, test cases, summary reports, trace matrix and other related technical documentation; Provide transparency to trace matrix test coverage and test progress for programs Plan, develop and execute software testing (both manual and automated) for medical devices, based on context and risks associated with the project Plan and coordinate testing with external test houses/NRTLs (Safety, EMI/EMC, Environmental, Shipping and handling, etc.) Participate in design and requirements reviews, analysis and support the development of documentation required for FDA device approval Support Software FMEA across various subsystems within the AET products, as per ISO 14971, IEC 62304, & IEC 80002-1 Ensure the adequacy of software design quality for AET products, including test design, protocol and results review and other supporting quality evidence Support the Validation / qualification of third-party software components and tools used for software development and verification/validation, including COTS/SOUP analysis Create, validate, and maintain test automation platforms Location: Andover, MA (Hybrid - must be local to Andover, MA) Education: BS in Engineering (Electrical, Biomedical or Computer Engineering) or Engineering related degree MS in Engineering (Electrical, Biomedical or Computer Engineering) or Engineering related degree preferred Experience: 2+ years of related experience (development or testing) with a BS degree 1+ years of related experience (development or testing) with an MS degree Competencies: Good understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activities Good understanding of reliability engineering, including developing reliability plans for product development, accelerated life testing design and analysis, reliability analysis and prediction Good understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD design control requirements for medical devices. Hands-on experience in test automation using MATLAB, Python, Java Script or LabVIEW Experience in developing sophisticated products that includes hardware, electrical and software Experience with test strategy development and execution across a range of electromechanical products, including test automation, performance testing, negative testing, code and coverage analysis, and compatibility testing Experience with embedded software programming, application software programming of test automation & test frameworks Experience using JAMA/Cognition or similar tools for requirements management Persistent, driven, self-motivated, keen to make an impact Excellent verbal and written communication skills Strong problem solving and troubleshooting skills Travel: <10% #LI-LS2 Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Join our talent community.