Sustaining Design Quality Engineering Manager

Smith+Nephew; Mansfield (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Tuition Reimbursement

Parental Leave

Paid Holidays

Paid Time Off

Volunteer Time Off

Job summary

Smith+Nephew is seeking a Quality Engineering leader in Mansfield, MA to drive design quality across the product lifecycle. You will lead Sustaining Design Quality Engineers, oversee design controls, and partner with cross-functional teams to ensure safety, performance, and regulatory compliance for Joint Repair products.

The role emphasizes development of engineering talent, regulatory submissions support, and ongoing improvement of DHF and related quality deliverables in a highly regulated

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years in medical device industry or similarly regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Proven leadership experience managing engineering teams.

Responsibilities

• Lead Sustaining Design Quality Engineers to support Joint Repair products.
• Drive product lifecycle management and resource allocation.
• Ensure robust design control practices and DHF integrity.
• Review and approve verification, validation, risk, CAPAs, and changes.
• Collaborate cross-functionally to meet safety, performance, and regulatory needs.
• Support regulatory submissions and participate in audits.
• Lead DHF assessments and drive continuous improvement.
• Provide technical leadership and mentor quality engineers.
• Influence stakeholders and resolve complex quality and technical challenges.

Skills

Leadership

Cross-functional collaboration

Design quality

FDA QSR knowledge

ISO 13485 knowledge

ISO 14971 knowledge

Mentorship

Regulatory submissions

Education

Bachelor of Science in Engineering

Job description

Life. Unlimited. At Smith+Naphew 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. 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

The anticipated base compensation range for this position is $xxxx000.00 to $xxxxx.00 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. You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, 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+Naphew 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 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 us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.