Smith+Nephew

Medical Device

PrincipalSystemArchitect

$165–236k Andover, Massachusetts, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Lead candidates.

The Brief

“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.

Medical Device
Problems you'll solve

Technical troubleshooting; Assess technical complexity; Identify risks early; Drive mitigation plans

Eligibility Requirements

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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