Design Quality Engineer

Smith+Nephew•Austin, TX

2d•Hybrid

About The Position

Smith+Nephew is seeking a Design Quality Engineer to join its ENT New Product Development team in Austin, WC. The role supports new medical device technologies from concept through development and helps ensure products meet rigorous quality and regulatory requirements. The engineer partners across functions and supports design controls, product testing, risk management, manufacturing, supplier and laboratory activities, continuous improvement, and post-market and audit processes.

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%.

Nice To Haves

A statistical background.

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 help ensure products meet required specifications and standards, and establish product safety and reliability 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.