About the Role
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.
Benefits
•Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging; Employee Inclusion Groups available.
•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.
