Life Unlimited. At SmithNephew 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 (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 SmithNephew 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. Stay connected and receive alerts for jobs like this by joining our talent community. We're more than just a company - we're a community Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at SN. Explore our new website and learn more about our mission, our team, and the opportunities we offer.