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# Design Quality Engineer

- **Company:** Smith & Nephew plc
- **Location:** Austin, TX, United States
- **Experience:** Starter
- **Contract:** Permanent contract
- **Skills:** Microsoft Excel, Artificial Intelligence, GXP
- **Published:** October 20, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=53ebe84c729957f2

## About the Role

* 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 .

## Description

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.
*