Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

Great opportunity to help achieve Life Unlimited mission for our Smith+Nephew customers. Through this role, you will have a great exposure to a highly collaborative environment working on diverse engineering designs and supporting the testing of the Smith+Nephew Sports Medicine products. This role is dedicated to New Product Development (NPD) initiatives and will act as a lead for system and/or subsystem verification activities.   

Smith+Nephew seeks an R&D Staff Systems Verification Engineer in the Sports Medicine business to drive and lead system verification efforts in partnership with the Systems Engineering and R&D New Product Development teams.

What will you be doing?

Autonomously lead large scale projects’ test activities, allocate test equipment and materials and align with Program Management and Cross-Functional on deliverables and timelineAct as a Subject Matter Expert (SME) in leading and supporting electrical test stands hardware and automation.Plan and conduct internal compliance testing per 60601-1 and 60601-1-2Identify, report, track, prioritize HW/SW defects using defects management systems (e.g. JIRA) and validate fixesSupport 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 strategySupport trouble shooting and root causing of Systems defects and enable R&D team identify fixesDraft 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 programsPlan, develop and execute software testing (both manual and automated) for medical devices, based on context and risks associated with the projectPlan 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 approvalSupport Software FMEA across various subsystems within the AET products, as per ISO 14971, IEC 62304, & IEC 80002-1Ensure the adequacy of software design quality for AET products, including test design, protocol and results review and other supporting quality evidenceSupport the Validation / qualification of third-party and internally developed software components and tools used for software development and verification/validation, including COTS/SOUP analysisCreate, validate, and maintain test automation platforms

What will you need to be successful?

Education:Bachelor of Science/Engineering degree in Electrical, Electronics, or Computer Engineering. Graduate degree is highly preferred.Experience:BS in engineering or science + 6 years of related experience or MS in engineering or science field + 3 year of related experienceA minimum of 2 years of experience in the medical device field or other regulated fieldA minimum of 2 years of experience in test verification and validationStrongly DesiredExperience in developing sophisticated products that includes hardware, electrical and softwareExperience 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 testingBasic experience with embedded software programming, application software programming of test automation & test frameworksBasic experience in software development and test processesSolid understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activitiesUnderstanding of reliability engineering, including developing reliability plans for product development, accelerated life testing design and analysis, reliability analysis and predictionDetailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD design control requirements for medical devices.In-depth experience with EMI/EMC test trouble shootingExperience with printed circuit board design implementation, design reviews, and electrical and electronic testingExperience using JAMA/Cognition or similar tools for requirements managementHands-on experience in one or more of the programming or scripting languages (C/C++, C#. Java, Python, JavaScript, Linux/bash commands etc.)Hands-on experience in test automation using MATLAB and LabVIEWPersistent, driven, self-motivated, keen to make an impactExcellent verbal and written communication skillsStrong problem solving and troubleshooting skillsTravel Requirements: Less than 10% domestic.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
Work/Life Balance:   PTO, Paid Holidays, Flex Holidays, Paid Community Service Day  Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance ProgramFlexibility: Hybrid Work Model (For most professional roles)Training: Hands-On, Team-Customized, MentorshipExtra Perks: Discounts on fitness clubs, travel and more

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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.

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