Sustaining Design Quality Engineering Manager
Smith+Nephew · Mansfield, MA
- Level
- Manager
- Team
- Quality
- Base pay
- $97k–$145k
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Medical devices
- Posted
- 23 days ago
The role in 30 seconds
A management quality role at Smith+Nephew (medical devices) in Mansfield, MA. Leading a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle.
- They ask for
- 5+ years · degree required
- Tools it names
- ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Internal audits
- Base pay
- $97k–$145k
- Day to day
- some off-shift / weekend coverage
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At a glance
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How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Smith+Nephew
We found 1 person at this company and state: 1 on the team. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Tom → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How does off-shift and weekend coverage work?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
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
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
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Show full description ↓Show less ↑
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