Design Quality Engineer

Smith & Nephew; Austin (TX); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Flexible Personal/Vacation Time Off

Paid Holidays

Health Savings Account

Job summary

Smith+Naphew in Austin is seeking a Design Quality Engineer to advance medical device development from concept to development. You will support design controls, verification and validation, sterilization and process validation, supplier qualification, and risk management to ensure products meet safety and regulatory standards.

You will partner with manufacturing and external labs, contribute to CAPA and internal audits, and help ensure compliance with FDA, ISO, MDR and GxP.

Qualifications

• Bachelor’s degree in Engineering.
• 0–2 years in the medical device or related industry.
• Understanding of Design Control and requirements such as FDA CFR 820, ISO 13485, EU MDR and GxP.
• Effective written and verbal communication skills; proficiency in Excel and AI tools.
• Ability to travel less than 5%.

Responsibilities

• Support design controls and quality activities including design verification and validation.
• Support manufacturing operations with expertise in product requirements, risk management and test methods.
• Ensure compliance with cGMP, QSR, FDA, ISO, MDR requirements.
• Partner with external laboratories and suppliers to communicate requirements and assess capabilities.
• Participate in CAPA, nonconformance and internal audit activities.
• Contribute to Post Market Surveillance and Management Review.

Skills

Communication

Project management

Teamwork

Education

Bachelor’s degree in Engineering

Tools

Excel

AI tools

Job description

Life. Unlimited. At Smith+Naphew 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:

• Discounts on fitness clubs
• travel
• and more!

#LI-HYBRID

Smith+Naphew 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.

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.

Smith+Naphew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Naphew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.