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 lifecycleDriving product lifecycle management initiatives and strategically allocating resources to meet business needsEnsuring robust and compliant design control practices, maintaining Design History File integrityReviewing and approving key quality deliverables including verification and validation, risk management, CAPAs, and design changesPartnering with cross functional teams to ensure products meet safety, performance, and regulatory requirementsSupporting regulatory submissions and representing design control activities during auditsLeading DHF assessments and conducting gap analyses to drive compliance and continuous improvementProviding technical leadership and mentorship to develop quality engineering talentInfluencing 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 field5+ years of experience in the medical device industry or a similarly regulated environmentStrong knowledge of FDA QSR, ISO 13485, and ISO 14971Proven leadership experience managing and developing engineering teamsAbility to collaborate cross functionally and communicate effectively at all levelsExperience driving design control activities and solving complex quality challengesCQE or Lead Auditor certification preferredThe 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 (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-HYBRIDSmith+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 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. SummaryLocation: Mansfield, MAType: Full time
Sustaining Design Quality Engineering Manager in mansfield at Unknown Company
This position is listed as full time and hybrid.