Senior Systems Engineer (Andover, MA)

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 bringing state of the art surgical visualization technologies to market, then this might be the role for you.

Smith+Nephew seeks a R&D Senior Systems Engineering in the Sports Medicine business to support system engineering activities for new product development programs. System Engineers at Smith+Nephew play an interdisciplinary role with a mission to provide engineering leadership to new product development teams. 

What will you be doing?

• Act as a subsystem lead, driving systems engineering activities through all stages of new product development.
• Own requirement development for key subsystems, including authoring requirements according to good requirement writing practices, building traceability, and driving team reviews.
• Define use cases and support appropriate translation of use cases to downstream user stories and requirements.
• Contribute to system architecture definition, including functional and physical architecture, and interface specifications.
• Use trade studies or other data-driven approaches to drive design decisions in collaboration with the team.
• Provide review throughout development to ensure detailed product design for your subsystem is aligned with system vision and architecture.
• Support integration activities including planning subsystem development priorities with your subsystem team to ensure system level integration goals are met. Support hands-on integration testing throughout development.
• Collaborate with Systems Verification Leads to establish verification and validation strategies that are aligned with requirement intent and statistically sound in approach.
• Support pre-clinical evaluations, including human factors formative and summative evaluations.
• 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
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Experience:

• Minimum 3+ years of experience working in R&D. Experience in medical device product development highly preferred.
• Exposure to medical device design control and standards including IEC 62304, ISO 14971, IEC 60601-1, IEC 60601-2-18, FDA and MDD preferred.
• Familiarity with image quality metrics and ISO/FDA consensus guidelines for endoscopy, or exposure to development for optical systems is a plus.
• Familiarity with cybersecurity standards and guidelines for medical devices.
• 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 leading new product development activities in medical device or another regulated industry.  
• Travel Requirements: <10%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/ 
 

Other reasons why you will love it here!

• Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
  Work/Life Balance:   PTO, Paid Holidays, Flex Holidays, Paid Community Service Day  
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, nat