Sustaining Design Quality Engineering Manager

Smith & Nephew; Mansfield (MA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

401(k) Matching Program

Tuition Reimbursement

Medical, Dental, Vision coverage

Job summary

Smith+Naphew in Mansfield, MA seeks a quality leader to guide a Sustaining Design Quality Engineering team. You will influence lifecycle quality programs, maintain robust design controls, and drive compliance across the full product lifecycle.

You will lead cross-functional collaborations, oversee verification/validation, risk management, CAPAs, and design changes, and mentor engineers to elevate quality practices while supporting regulatory activities and audits.

Qualifications

• Bachelor of Science in Engineering or related field.
• 5+ years in medical device or regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971.
• Proven leadership experience managing and developing engineering teams.
• Ability to collaborate cross functionally and communicate effectively at all levels.
• CQE or Lead Auditor certification preferred.

Responsibilities

• Lead a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle.
• Drive product lifecycle management initiatives and strategically allocate resources to meet business needs.
• Ensure robust and compliant design control practices, maintaining Design History File integrity.
• Reviewing and approving 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.

Skills

Leadership

Quality engineering

Regulatory knowledge

Cross-functional collaboration

Mentorship

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.

• 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

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/).

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.

We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.

Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.