Design Quality Engineer
Smith+Nephew · Austin, TX
- Level
- Engineer
- Team
- Quality
- Travel
- 5%
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- Yesterday
The role in 30 seconds
An engineer-level quality role at Smith+Nephew (medical devices) in Austin, TX. At Smith+Nephew we design and manufacture technology that takes the limits off living.
- They ask for
- 2+ years · degree required
- Tools it names
- CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Internal audits
- Day to day
- some off-shift / weekend coverage · about 5% travel
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?
- The posting says about 5% travel. Between which sites?
- 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
and assess capabilities.
- ✓Support continuous improvement activities, including CAPA, nonconformance and internal audit activities.
- ✓Contribute to Post Market Surveillance, Management Review and audit and inspection activities.
What will you need to be successful?
- ✓Bachelor’s degree in Engineering.
- ✓0 to 2 years of experience in the medical device or a related industry, with a general or basic understanding of Design Control and
requirements
such as FDA CFR 820, ISO 13485, EU MDR and GxP.
- ✓Ability to manage and prioritize multiple projects, tasks and deadlines while working effectively as part of a team.
- ✓Effective written and verbal communication skills, with proficiency in Excel and AI tools.
- ✓A statistical background is preferred.
- ✓Ability to travel less than 5%
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 .
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!
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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.
Join our ENT New Product Development team as a Design Quality Engineer in Austin WC, where you will help bring safe, reliable medical device technologies from concept through development. This is an opportunity to build your quality engineering expertise while partnering across functions and helping ensure new products meet rigorous quality and regulatory requirements.
What will you be doing?
- •Support design controls and quality activities, including design verification and validation, sterilization validation, process validation, supplier qualification, test methods, capability studies and risk management documentation.
- •Develop methods and procedures that help ensure products meet required specifications and standards, with product safety and reliability established through appropriate testing.
- •Support manufacturing operations with expertise in product requirements, risk management, test methods and statistical analysis.
- •Help ensure compliance with applicable quality and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.
- •Partner with external laboratories and suppliers to communicate product and process