System Architect (Andover, MA)

Smith & Nephew•Andover, MA

43d•Hybrid

About The Position

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 leading teams to bring state of the art surgical visualization technologies to market, then this might be the role for you. Smith+Nephew seeks a Systems Architect in the Sports Medicine business to lead system engineering activities for our next generation of surgical visualization products. System Architects at Smith+Nephew provide technical leadership to new product development teams, working closely with cross-functional teams to understand the underlying customer needs and motivation driving programs and conceptualizing and executing on solutions to meet those needs with our R&D teams.

Requirements

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.
Minimum 10+ years of experience working in systems engineering / product development on complex, software-driven electro mechanical products.
Proven track record acting as a Systems or Technical Lead for complex programs.
Expertise in partitioning and decomposing complex engineering problems into solvable problems.
A strong understanding of system engineering and architecture principles and comfort in both applying and championing them within an organization.
Experience using Cognition Cockpit or similar tools for requirements management.
Experience using Enterprise Architect or similar tools for model-based systems engineering related activities.
Experience developing embedded systems with optics for medical applications.
An understanding of medical device design control and standards including IEC 62304, ISO 14971, IEC 60601-1, IEC 60601-2-18, FDA and MDD.
Familiarity with image quality metrics and ISO/FDA consensus guidelines for endoscopy.
Familiarity with cybersecurity standards and guidelines for medical devices.
Experience leading new product development activities in medical device or another regulated industry.

Nice To Haves

INCOSE ASEP or CSEP certification preferred.

Responsibilities

Provide technical project leadership to cross-functional teams and drive engineering activities through all stages of new product development.
Define Systems Engineering strategy for your program, including appropriate requirement decomposition approaches, interface management strategy and integration plan.
Act as Systems Engineering team lead for your program, working with a team of Systems Engineers to deliver a complete set of Systems Engineering deliverables.
Clearly articulate and drive team alignment on program mission and stakeholder needs. Directly interface with users and other stakeholders to ensure an understanding of stakeholder needs.
Conceptualize and create system architecture for next generation surgical visualization platform, including functional and physical architecture and interface definition.
Drive architectural decisions on the program using trade studies or other data-driven approaches. Manage cross-functional team discussions related to architecture decisions.
Champion and apply system architecture principles throughout product design and development to drive reliable, flexible, and maintainable systems.
Provide guidance to R&D team members throughout development to ensure detailed product design is aligned with agreed system architecture.
Drive integration activities including identification of integration goals and success criteria. Support hands-on integration and stress testing throughout development.
Support pre-clinical and clinical evaluations, including human factors formative and summative evaluations.
Oversee & support other systems engineering activities for your program including, use case & requirement development activities, appropriate translation of use cases to downstream user stories and subsystem requirements, and development of verification strategies.
Remain current with the Systems Engineering discipline and champion good Systems Engineering practice and improvement initiatives.