Design Quality Engineer
- Location
- Austin, TX · Hybrid
- Job type
- Full-time
- Level
- Mid-level
- Education
- Bachelor's degree
- Listed
- 16 days ago
Skills & highlights for this role
- Design controls
- Design verification and validation
- Risk management
- Test methods
- Regulatory compliance (cGMP, QSR, FDA, ISO, IEC, UL, EN, MDD, MDR)
- FDA CFR 820
- ISO 13485
- EU MDR
- GxP
- Microsoft Excel
- Written and verbal communication
- Multi-project prioritization
Also useful
- Statistical analysis
- Sterilization validation
- Process validation
- Supplier qualification
- Capability studies
- AI tools
- Medical device industry experience
About 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 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. 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
- Stay connected by joining our Talent Community.
- We're more than just a company - we're a community!
- Follow us on L inkedIn 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.
Equal opportunity and legal notices
Discounts on fitness clubs, travel and more! #LI-HYBRID 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.
From Smith & Nephew's careers page, first listed on Rolev.ai on October 25, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
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Common questions
Where is the Design Quality Engineer job at Smith & Nephew located?
This Design Quality Engineer position at Smith & Nephew is located in Austin, TX (Hybrid). Always check Smith & Nephew's application page for specific state eligibility or relocation policies.
What qualifications are required for Design Quality Engineer at Smith & Nephew?
For the Design Quality Engineer role, Smith & Nephew highlights a bachelor's degree; experience with Design controls, Design verification and validation, Risk management, Test methods, Regulatory compliance (cGMP, QSR, FDA, ISO, IEC, UL, EN, MDD, MDR), FDA CFR 820. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Design Quality Engineer position at Smith & Nephew?
This listing links directly to Smith & Nephew's Workday application page. You can apply directly on Smith & Nephew's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.