Senior Staff Digital Systems Engineer (Andover, MA)

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 (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