Senior Staff Digital Systems Engineer (Andover, MA)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
The R&D Senior Staff Digital Systems Engineer in the Advanced Wound Management (AWM) business will drive and lead system engineering for new product development (NPD). The role will report directly into the R&D Director of AWM Software Development and Digitally Enabled Products. The successful candidate will bring a demonstrated track record of delivering digital / wearable product innovations to the market; has in-depth knowledge in systems engineering methodology and best practices; and has a team player mentality to help the team deliver complex digital product solutions.
What will you be doing?

• Technical project lead accountable for all design & development activities and technical aspects of the program in partnership with the technical functional leads and/or other Systems Engineering leads
• Drive adoption of Systems Engineering concepts and best practices throughout the organization
• Own requirement development for the program, including drafting of User Needs and Design Inputs
• Define complex system strategy and architecture - including functional, physical and interface requirement specifications
• Develop verification and validation strategy for sophisticated medical systems
• Support pre-clinical and clinical evaluations
• Support system integration builds
• Remain current with the knowledge and practice of systems engineering and requirements management
• Analyze complexity and handle risk

What will you need to be successful?

• Education:
  
  • BS degree in Computer Science, Computer Engineering, Electrical Engineering or related technical field
  • MS degree in Engineering or in a related field preferred

• Certifications/Licenses:
  • INCOSE training and certification is a plus

• Experience:
  • 8+ years of related experience with a BS degree
  • 5+ Years of related experience with an MS degree
• Consistent track record delivering innovative medical device products to the market
• Solid understanding of systems engineering process and design control processes
• Breadth of knowledge across software, electrical, and mechanical engineering fields
• Has brought first-of-its-kind solutions to the marketplace
• Expertise in partitioning and decomposing complex engineering problems into solvable problems
• Experience working with agile development methodologies
• Skilled in writing requirements and strategizing verification and validation plans
• Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDR design control requirements 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
• Persistent, driven, self-motivated, keen to make an impact
• Excellent organizational, documentation and written/verbal communication skills
• Travel Requirement: 15%

You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website ( ).
Other reasons why you will love it here!

• Your Future: 4 01k 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

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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