Smith+Nephew
Medical Device
PrincipalSystemArchitect
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“Principal System Architect at Smith+Nephew. Skills: System architecture, Requirements engineering, Medical device development, Digital wearables. Lead system-level design. Translate user needs into requirements”
What You'll Achieve.
Deliver impact
Industry & Context.
Technical troubleshooting; Assess technical complexity; Identify risks early; Drive mitigation plans
Up to 15% travel as needed
What They're Looking For.
Must Have
B. S. in Computer Science, Computer Engineering, Electrical Engineering, or a related technical field, 14+ years of related experience with a B. S., 10+ years of related experience with an M. S., Experience with Agile development, Experience with DevSecOps, Experience with CI/CD, Experience with test automation, Experience with Infrastructure as Code (IaC) tools, Proficient with SDLC best practices, Proficient with modern development toolchains, Demonstrated record of delivering innovative medical device products to market, understanding of systems engineering processes, understanding of 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, Expert in decomposing complex systems into executable work packages, Skilled in authoring requirements, Skilled in defining verification and validation (V&V) plans, Detailed understanding of IEC 62304, Detailed understanding of ISO 14971, Detailed understanding of IEC 60601, Detailed understanding of FDA/EU MDR design control requirements for medical devices, Experience with requirements management tools, Experience with model-based systems engineering (MBSE) tools
Nice to Have
M. S. in Engineering or a related field, INCOSE training and certification
What You'll Do.
Lead system-level design
Translate user needs into requirements
Define system architecture
Guide implementation across disciplines
Serve as technical lead
Partner with functional leads
Champion Systems Engineering adoption
Own requirements development
Define system strategy
Develop verification strategies
Develop validation strategies
Support pre-clinical evaluations
Support clinical evaluations
Plan system integration builds
Support issue resolution
Stay current on systems engineering practices
Support system risk management activities
Assess technical complexity
Drive mitigation plans
How You'll Work.
Team & Collaboration
Partnering with functional leads; Partnering with Systems Engineering peers; Champion adoption of Systems Engineering concepts across the organization; Issue resolution across disciplines
Communication Scope
Written communication skills; Verbal communication skills
Process & Methodology
Drive mitigation plans through the development lifecycle
Full Job Description
**Life Unlimited.** At Smith+Nephew we design and manufacture technology that takes the limits off living. As a **Principal System Architect** 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,
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