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About the Role
As a Design Quality Engineer on the ENT New Product Development team, you will help bring safe, reliable medical device technologies from concept through development. This role offers an opportunity to build quality engineering expertise while ensuring new products meet rigorous quality and regulatory requirements.
Responsibilities
- 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 to 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.
- 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.
Requirements
- Bachelor’s degree in Engineering.
- 0 to 2 years of experience in the medical device or a related industry.
- 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.
- Proficiency in Excel and AI tools.
- Ability to travel less than 5%
Skills
- Statistical background is preferred.
- Excel
- AI tools
Location
- Austin WC
Work Type
- Hybrid Work Model
Experience Level
- 0 to 2 years
Education Level
- Bachelor’s degree in Engineering
Benefits
- 401k Matching Program
- 401k Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible Personal/Vacation Time Off
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical
- Dental
- Vision
- Health Savings Account (Employer Contribution of $500+ annually)
- Employee Assistance Program
- Parental Leave
- Fertility and Adoption Assistance Program
- Discounts on fitness clubs, travel and more!
About the Company
- Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
- We believe in creating the greatest good for society.
- Our strongest investments are in our people and the patients we serve.
- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging
- 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.
Equal Opportunity
- 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.