Principal System Engineer

Smith+Nephew•Andover, MA

2d•Hybrid

About The Position

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. 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.

Requirements

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.

Nice To Haves

M.S. in Engineering or a related field
INCOSE training and certification is a plus

Responsibilities

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.