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Staff Systems Engineer

3 months ago

Andover, United States Smith & Nephew Full time
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 interest contributing to a groundbreaking technology that does not currently exist in Sports Medicine surgery today, then this might be the role for you.

We are seeking a R&D Staff Systems Engineering in the Sports Medicine business to lead system engineering for new product development. System Engineers at Smith+Nephew play an interdisciplinary role with a mission to provide engineering leadership to NPD teams.

What will you be doing?

Drive all engineering activities and technical aspects of the program in partnership with technical leads and program managers
  • Clearly articulate program mission and stakeholder needs
  • Own requirement development including user needs and system requirements
  • Define system architecture including functional, physical, and interface specifications
  • Support integration activities including identification of integration goals and success criteria
  • Develop verification and validation strategies in collaboration with test team
  • Support pre-clinical and clinical evaluations
  • Analyze product and project risk throughout development
  • Remain current with the systems engineer discipline and champion good systems engineering practice and improvement initiatives
What will you need to be successful?
  • Education: 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.
  • Experience:
    • Minimum 6+ years of experience with a BS degree or 3+ years with a MS degree working in R&D on complex products.
    • Consistent track record of delivering innovate medical device products to the market
    • A strong understanding of medical device design control and standards including IEC 62304, ISO 14971, FDA and MDD
    • Experience developing sophisticated products that include hardware and software. Experience with digital, mobile or cloud-based products a plus
    • Expertise in partitioning and decomposing complex engineering problems into solvable problems
    • Skilled in writing requirements, developing system architecture, and driving product trade-off decisions
    • Experience using Cognition Cockpit or similar tools for requirements management
    • Experience using Enterprise Architect or similar tools for model-based systems engineering related activities
    • Persistent, driven, self-motivated, keen to make an impact
    • Excellent organizational, documentation and written/verbal communication skills
  • Leadership if any: Experience leading new product development activities in medical device or another regulated industry.
  • Travel Requirements: