Sustaining Design Quality Engineering Manager
Smith+Nephew
Summary
Are you a quality leader passionate about driving excellence across the full product lifecycle? This is an opportunity to lead a high performing engineering team, influence strategic initiatives, and ensure life enhancing medical technologies remain safe, effective, and compliant. Based in Mansfield, MA, you will play a critical role in sustaining innovation while shaping quality practices across the organization.
Job description
What will you be doing?
- Leading a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle
- Driving product lifecycle management initiatives and strategically allocating resources to meet business needs
- Ensuring robust and compliant design control practices, maintaining Design History File integrity
- Reviewing and approving key quality deliverables including verification and validation, risk management, CAPAs, and design changes
- Partnering with cross functional teams to ensure products meet safety, performance, and regulatory requirements
- Supporting regulatory submissions and representing design control activities during audits
- Leading DHF assessments and conducting gap analyses to drive compliance and continuous improvement
- Providing technical leadership and mentorship to develop quality engineering talent
- Influencing stakeholders and resolving complex quality, technical, and operational challenges.
What will you need to be successful?
- Bachelor of Science in Engineering or a related technical field
- 5+ years of experience in the medical device industry or a similarly regulated environment
- Strong knowledge of FDA QSR, ISO 13485, and ISO 14971
- Proven leadership experience managing and developing engineering teams
- Ability to collaborate cross functionally and communicate effectively at all levels
- Experience driving design control activities and solving complex quality challenges
- CQE or Lead Auditor certification preferred
Requirements
- Bachelor of Science in Engineering or a related technical field
- 5+ years of experience in the medical device industry or a similarly regulated environment
- Strong knowledge of FDA QSR, ISO 13485, and ISO 14971
- Proven leadership experience managing and developing engineering teams
- Ability to collaborate cross functionally and communicate effectively at all levels
- Experience driving design control activities and solving complex quality challenges
- CQE or Lead Auditor certification preferred
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- 401(k) Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Medical Leave Programs
- Parental Leave
- Fertility & Adoption Assistance
- Generous PTO
- Paid Company Holidays
- Flex Holidays
- Paid Community Service Day
- Health Savings Account
- Employee Assistance Program
- Wellness Offerings
- Fitness Club Discounts
- Travel Discounts
- 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.