R&D Staff Systems Engineer - Visualization Systems (Andover, MA)

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

If you have a passion for helping improve the lives of patients and an interest in bringing innovative surgical visualization technologies to market, then this might be the role for you.

Smith+Nephew seeks a R&D Staff Systems Engineer - Visualization Systems in the Sports Medicine business to lead system engineering activities for new product development programs. System Engineers at Smith+Nephew play an interdisciplinary role with a mission to provide engineering leadership to NPD teams.

What will you be doing?

• Provide technical project leadership to cross-functional teams and drive engineering activities through all stages of new product development.

• Clearly articulate and drive team alignment on program mission and stakeholder needs. Directly collaborate with users and other stakeholders to ensure an understanding of stakeholder needs.

• Own requirement development including user needs and system requirements definition and defining appropriate requirement decomposition approaches.

• Own use case definition including driving use case workshops and ensuring appropriate translation of use cases to downstream user stories and subsystem requirements.

• Own system architecture definition including functional, physical, and interface specifications.

• Drive architectural decisions on the program using trade studies or other data-driven approaches.

• Provide guidance to R&D team members throughout development to ensure detailed product design is aligned with agreed requirements and system architecture.

• Drive integration activities including identification of integration goals and success criteria. Support hands-on integration and stress testing throughout development.

• Collaborate with Systems Verification Leads to establish verification and validation strategies that are aligned with requirement intent and statistically sound in approach.

• Support pre-clinical and clinical evaluations, including human factors formative and summative evaluations.

• Remain current with the systems engineer discipline and champion good systems engineering practice and improvement initiatives.

• This position is Hybrid only to those local to the Andover, MA location.

What will you need to be successful?

• Education: Minimum BS in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related technical degree. Preferred MS in Systems Engineering or other formal Systems Engineering training.

• Experience:

  • Minimum 6+ years of experience working in R&D on complex products.

  • Consistent track record of delivering innovate medical device products to the market.

  • A strong understanding of medical device design control and standards including IEC 62304, ISO 14971, IEC 60601-1, IEC 60601-2-18, FDA and MDD.

  • Experience developing embedded systems with optics for medical applications.

  • Familiarity with image quality metrics and ISO/FDA consensus guidelines for endoscopy.

  • Familiarity with cybersecurity standards and guidelines for medical devices.

  • Expertise in partitioning and decomposing complex engineering problems into solvable problems.

  • Experience using Cognition Cockpit or similar tools for requirements management.

  • Experience using Enterprise Architect or similar tools for model-based systems engineering related activities.

  • Persistent, driven, self-motivated, keen to make an impact.

  • Excellent organizational, documentation and written/verbal communication skills.

• Leadership: Experience leading new product development activities in medical device or another regulated industry.

• Travel Requirements: <10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients 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.