Design Quality Engineer
Smith+Nephew · Mansfield, MA
- Level
- Engineer
- Team
- Quality
- Base pay
- $74k–$112k
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- 3 days ago
The role in 30 seconds
An engineer-level quality role at Smith+Nephew (medical devices) in Mansfield, MA. You will partner with cross-functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.
- They ask for
- 2+ years · degree required
- Tools it names
- Six Sigma, Root cause, FMEA, CAPA, ISO 13485, FDA / GMP
- Base pay
- $74k–$112k
- Day to day
- some off-shift / weekend coverage
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- 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, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 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
throughout the product lifecycle.
- ✓Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
- ✓Provide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.
- ✓Drive continuous improvement initiatives using quality metrics, post-market data, and operational performance insights.
What will you need to be successful?
Required Qualifications
- ✓Bachelor of Science degree in Engineering or a related technical discipline.
- ✓Minimum of 2 years of experience in the medical device industry or another regulated environment.
- ✓Working knowledge of: FDA Quality System Regulations (QSR) ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes
- ✓Strong analytical, communication, collaboration, and problem-solving skills.
- ✓Ability to develop and implement solutions to complex quality challenges.
Preferred Qualifications
- ✓Certified Quality Engineer (CQE).
- ✓Six Sigma certification.
- ✓Experience supporting sustaining engineering and product lifecycle management.
- ✓Experience participating in audits, inspections, and regulatory submissions.
Requirements
- ✓Less than 10% travel.
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 Options, 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
- ✓Training: Hands-On, Team-Customized, Mentorship
- ✓Extra Perks: Discounts on fitness clubs, travel and more!
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Life Unlimited. At Smith+Nephew , we design and manufacture technology that takes the limits off living.
Are you passionate about quality, innovation, and patient safety? Do you enjoy working across functions to ensure medical devices remain safe, effective, and compliant throughout their lifecycle?
Join Smith+Nephew as a Design Quality Engineer and play a key role in supporting our Sports Medicine Joint Repair portfolio while helping improve outcomes for patients around the world.
As a Design Quality Engineer, you will partner with cross-functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.
Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization
What will you be doing?
- •Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
- •Lead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.
- •Review and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.
- •Investigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
- •Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System
Physical Demands
- •Primarily seated work with occasional light lifting.
Travel