Design Quality Engineer
Smith+Nephew
Summary
Join our ENT New Product Development team as a Design Quality Engineer in Austin, 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.
Job description
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%.
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
- Knowledge of FDA CFR 820, ISO 13485, EU MDR and GxP
- Ability to manage and prioritize multiple projects, tasks and deadlines
- Ability to work effectively as part of a team
- Effective written and verbal communication skills
- Proficiency in Excel and AI tools
- Statistical background preferred
- Ability to travel less than 5%
Benefits
- 401(k) Matching
- 401(k) Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible Time Off
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account
- Employee Assistance Program
- Parental Leave
- Fertility & Adoption Assistance
- Hybrid Work Model
- Hands-On Training
- Team-Customized Training
- Mentorship
- Fitness Club Discounts
- Travel Discounts
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.