Director Systems Engineering

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Smith+Nephew seeks an R&D Director of Systems Engineering in the Sports Medicine business to drive and lead system engineering efforts in partnership with the Systems Verification Team and R&D New Product Development teams. The role will work with the R&D Sr. Director of Sports Medicine Systems Engineering and Advanced Technology Development.
What will you be doing?
• Provide functional leadership and direction to the AET Systems Engineering team to drive AET New Product Development Programs
• Coach, mentor and enable systems team members
• Ensure quality of systems engineering team deliverables, especially program charter, requirements development for the program (User Needs and Design Inputs), system architecture (including functional, physical and interface requirement specifications), verification and validation strategies
• Remain current with the knowledge and practice of systems engineering and requirements management
• Enable alignment with cross-functional partners on NDP Programs
• Responsible for and drives high impact strategic initiatives
• Analyze complexity and handle risks

What will you need to be successful?
• Experience in the medical device field or other regulated field
• 5+ years of direct management experience required.

Desired:
• Formal systems engineering training (degree or INCOSE certification)
• Experience in developing sophisticated products that includes hardware, electrical and software
• Experience in software development and test processes
• Solid understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activities
• Solid understanding of reliability engineering, including developing reliability plans for product development, accelerated life testing design and analysis, reliability analysis and prediction
• Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD design control requirements for medical devices
• Experience using JAMA/Cognition or similar tools for requirements management
• Hands-on experience in one or more of the programming or scripting languages (C/C++, C#, Java, Python, JavaScript etc.)
• Persistent, driven, self-motivated, keen to make an impact
• Excellent verbal and written communication skills
• Strong problem solving and troubleshooting skills
Education:
BS in related Engineering/Science/Industrial Design field and 9 years of related experience, or MS in Business, Science, Marketing or Engineering field OR BS in related Engineering field and 6 years of related experience.

You Unlimited.

• The anticipated base compensation range for this position is $165,250 - $271,375 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.
• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, 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.