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 l