Design Quality Engineer

About the Role

Join the ENT New Product Development team as a Design Quality Engineer in Austin WC. This role will support bringing safe, reliable medical device technologies from concept through development, building quality engineering expertise, and ensuring new products meet rigorous quality and regulatory requirements.

Key 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.
• Help ensure compliance with applicable quality and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and MDR.
• 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 & Tech Stack

• 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.
• A statistical background is preferred.
• Ability to travel less than 5%.