Sustaining Design Quality Engineering Manager

About the role

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. 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.

Responsibilities

• 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

Qualifications

• Bachelor of Science in Engineering or a related technical field
• 5+ years of experience in the medical device industry or a similarly regulated environment

Skills

• 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, and vision coverage
• 401(k)
• Tuition reimbursement
• Medical leave programs
• Parental leave
• Generous PTO
• Paid company holidays
• 8 hours of volunteer time annually
• Wellness offerings such as EAP
• 401k Matching Program
• 401k Plus Program
• Discounted Stock Purchase Plan
• Flexible Personal Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Health Savings Account Employer Contribution of