Principal System Engineer

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. As a Principal Digital Systems Engineer for Smith+Nephew Advanced Wound Management (AWM) R&D, you will lead system-level design from concept through launch for wearable sensors and connected cloud solutions. You will translate user needs and stakeholder inputs into clear requirements, define and document system architecture, and guide implementation across hardware, firmware, software, and verification activities.

What will you need to be successful?

The ideal candidate brings a strong medical device foundation, deep knowledge of systems engineering methods and requirements management, and a track record delivering innovative digital wearables to market. This role reports to the R&D Director, AWM Software Development and Digitally Enabled Products.

• Serve as technical lead accountable for system design and development, partnering with functional leads and Systems Engineering peers.
• Champion adoption of Systems Engineering concepts, tools, and best practices across the organization.
• Own requirements development for assigned programs, including drafting User Needs and Design Inputs.
• Define system strategy and architecture, including functional, physical, and interface specifications.
• Develop end-to-end verification and validation strategies for complex medical systems.
• Support pre-clinical and clinical evaluations, including protocol input and technical troubleshooting as needed.
• Plan and support system integration builds and issue resolution across disciplines.
• Stay current on systems engineering practices, standards, and requirements management approaches.
• Support system risk management activities, such as FMEA’s and risk/hazard analysis
• Assess technical complexity, identify risks early, and drive mitigation plans through the development lifecycle.

Location:

• Andover, MA

Education:

B.S. in Computer Science, Computer Engineering, Electrical Engineering, or a related technical field (required), M.S. in Engineering or a related field (preferred)

Certifications/Licenses:

INCOSE training and certification is a plus

What will you need to be successful?

• 14+ years of related experience with a B.S.
• 10+ years of related experience with an M.S.
• Experience with Agile development and DevSecOps (CI/CD, test automation) and Infrastructure as Code (IaC) tools (e.g., Terraform).
• Proficient with SDLC best practices and modern development toolchains (e.g., Git/GitLab, Jira).
• Demonstrated record of delivering innovative medical device products to market.
• Strong understanding of systems engineering processes and medical device design controls.
• Working knowledge across software, electrical, and mechanical engineering disciplines.
• Experience bringing first-of-its-kind solutions to the marketplace.
• Expert in decomposing complex systems into clear, testable requirements and executable work packages.
• Skilled in authoring requirements and defining verification and validation (V&V) plans.
• Detailed understanding of IEC 62304, ISO 14971, IEC 60601, and FDA/EU MDR design control requirements for medical devices.
• Experience with requirements management tools (e.g., Cognition Cockpit or equivalent).
• Experience with model-based systems engineering (MBSE) tools (e.g., Enterprise Architect or equivalent).
• Self-directed and outcomes-focused, with a strong drive to deliver impact.
• Excellent organization, documentation, and written/verbal communication skills.

Travel: Up to 15% as needed

You Unlimited.

• The anticipated base compensation range for this position is $ 165,250-$236,000 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.

• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  

• Work/Life Balance: Flexible Personal/Vacation Time Off, 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!  

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.