Job description

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. 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 ( 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 #LI-HYBRID Smith Nephew 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 L inkedIn 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.

Requirements

Must-haves

Life. Unlimited. At Smith Nephew we design and manufacture technology that takes the limits off living.
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
The anticipated base compensation range for this position is $xxxx000.00 to $xxxxx.00 USD annually.
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/).
Work/Life Balance: Flexible Personal Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

Nice-to-haves

CQE or Lead Auditor certification preferred

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long

Benefits

Benefits detected in the listing.

Dental

Vision

401k

401(K)

Pto

Parental Leave

Wellness