Design Quality Engineer 2

About 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 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.

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!

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