New · posted Oct 22
Smith+Nephew · Medical Devices
Design Quality Engineer
- Austin, TX
- Hybrid
- Full-time
- Associate & Specialist
Open until filled
The role
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 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!
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.
What you need
What you'll do
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 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.
Pay and benefits
Smith+Nephew didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
401k matching program
Discounted stock purchase plan
Tuition reimbursement
Medical, dental and vision insurance
Flexible paid time off and paid holidays
Parental leave
Where you'll work
Austin, TXHybridOpen in Maps (opens in a new tab)
More jobs in Austin, TXEqual opportunity, accessibility and legal noticesSmith+Nephew's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in Texas6 roles publishing pay
Associate & Specialist roles in the US177 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Texas (middle half) | $73,000 | $75,750 | $79,625 |
| All US (middle half) | $59,000 | $81,000 | $93,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Smith+Nephew's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk6
- Collaboration and leadership6
- GMP and compliance4
- Lab testing and methods4
- Documentation and SOPs2
- Regulatory submissions2
- Investigations and CAPA1
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
Smith+Nephew on Regulatory Jobs
- 13
- Open roles
- 11
- Distinct roles
- 8
- Locations
By discipline
- Quality9 69%
- Regulatory4 31%
By level
- Senior & Principal6 46%
- Associate & Specialist4 31%
- Manager2 15%
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Design Quality Engineer at Smith+Nephew
Open until filled.