Staff Systems Verification Engineer (Andover, MA)

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 timeline
• Act 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 60601-1-2
• 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 and internally developed software components and tools used for software development and verification/validation, including COTS/SOUP analysis
• Create, 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 experience
  • A minimum of 2 years of experience in the medical device field or other regulated field
  • A minimum of 2 years of experience in test verification and validation
• Strongly Desired
  • 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
  • Basic experience with embedded software programming, application software programming of test automation & test frameworks
  • Basic experience in software development and test processes
  • Solid understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activities
  • Understanding of reliability engineering, including developing reliability plans for product development, accelerated life testing design and analysis, reliability analysis and prediction
  • Detailed 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 shooting
  • Experience with printed circuit board design implementation, design reviews, and electrical and electronic testing
  • Experience using JAMA/Cognition or similar tools for requirements management
  • Hands-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 LabVIEW
  • Persistent, driven, self-motivated, keen to make an impact
  • Excellent verbal and written communication skills
  • Strong problem solving and troubleshooting skills
• Travel 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 Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra 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.