New · posted Nov 12
Smith+Nephew · Medical Devices
Design Quality Engineer 2
- Austin, TX
- Hybrid
- Full-time
- Senior & Principal
The role
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Join our Quality team in Austin and help bring safe, reliable medical device innovations to life. As a Quality Engineer, you will be a key quality partner for new product development, working across functions to ensure products meet demanding quality, safety, performance and regulatory requirements.
What will you need to be successful?
- A 4-year technical degree is required, a bachelor's degree in biomedical or mechanical engineering is highly preferred
- 2-5 years in the medical device industry
- Familiarity with process development and new product development is a plus.
- Experience with design verification and validation, process or sterilization validation, risk management, test methods, supplier qualification and investigation or CAPA activities.
- Working knowledge of relevant medical device regulations and standards, including US FDA, QSR, cGMP, ISO and EU MDR requirements
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?
- Provide quality leadership for new product development project teams, serving as the Quality Engineering representative and partnering with cross functional teams.
- Generate, approve and manage design verification, design validation, sterilization validation, process validation, supplier qualification and test method activities.
- Develop protocols, capability studies and risk assessments to support product safety, reliability and overall risk management.
- Ensure compliance with applicable product standards and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN and EU MDR requirements.
- Support manufacturing operations with expertise in product requirements, inspection and test methods, root cause investigations and issue resolution.
- Partner with external laboratories and suppliers to communicate product and process requirements and assess capabilities.
- Support continuous improvement and compliance activities, including CAPA resolution and nonconformance investigations.
- Support Post Market Surveillance, Quality Management Reviews and internal and external audits or inspections.
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
Discounted stock purchase plan
Tuition reimbursement
Medical, dental, vision
Paid holidays and flexible time off
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 · November 12, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US50 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $114,125 | $128,000 | $134,750 |
Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 77 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Smith+Nephew's own promotion track.
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
- GMP and compliance5
- Collaboration and leadership5
- Lab testing and methods4
- Investigations and CAPA3
- Validation and qualification2
- Regulatory submissions2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
Company hiring pulse
Smith+Nephew on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 4
- Locations
By discipline
- Quality8 100%
By level
- Associate & Specialist4 50%
- Senior & Principal3 38%
- Manager1 13%
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Design Quality Engineer 2 at Smith+Nephew
Open until filled.