Director Systems Engineering
Smith+Nephew
Summary
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.
Job description
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.
Requirements
- Experience in the medical device field or other regulated field
- 5+ years of direct management experience required
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Tuition Reimbursement
- Medical Leave Programs
- Parental Leave
- Generous PTO
- Paid Company Holidays
- Volunteer Time
- Wellness Offerings
- EAP
- Discounted Stock Options
- Health Savings Account
- Fertility & Adoption Assistance
- Hybrid Work Model
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.