Smith and Nephew is seeking 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 (NPD) teams. The role will work with the R&D Manager of Systems Verification. The position will be based in Andover, MA.
Responsibilities:
- 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 test stands hardware and software automation and scripting.
- 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:
- 6+ years of related experience (development or testing) with a BS degree
- 3+ years of related experience (development or testing) with an MS degree
- A minimum of 2 years of experience in the medical device field or other regulated industry
Competencies:
- Solid understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activities
- Solid 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.
- 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
- Experience using LDRA (or other tools) for test automation, unit testing and code coverage
- Persistent, driven, self-motivated, keen to make an impact
- Excellent verbal and written communication skills
- Strong problem solving and troubleshooting skills
Travel:
Job Type: Full-time
Pay: $160,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Health savings account
- Paid time off
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
Ability to commute/relocate:
- Andover, MA 01810: Reliably commute or planning to relocate before starting work (Required)
Experience:
- test verification: 5 years (Required)
- regulated industry: 3 years (Required)
- Embedded system: 2 years (Required)
Work Location: Hybrid remote in Andover, MA 01810
