Design Quality Engineer — Hybrid, Growth & Impact

Smith Nephew; Austin (TX); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Paid Holidays

Flexible Personal/Vacation Time Off

Job summary

Smith+Né is seeking a Design Quality Engineer in Austin, TX to support design controls, verification and validation, and risk management for ENT products from concept through development. You will collaborate across functions to ensure products meet regulatory requirements and quality standards.

Applicants should have a Bachelor’s degree in Engineering and up to 2 years of medical device experience, with knowledge of FDA CFR 820, ISO 13485, and GxP.

Qualifications

• Bachelor's degree in Engineering or related field.
• 0–2 years of experience in medical devices or related industry with basic understanding of design controls.
• Strong communication and Excel skills; familiarity with AI tools is a plus.

Responsibilities

• Support design controls and quality activities, including 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 specifications with safety and reliability through testing.
• Support manufacturing with product requirements, risk management, test methods and statistical analysis.
• Help ensure compliance with cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.
• Coordinate with external labs and suppliers to communicate requirements and assess capabilities.
• Assist continuous improvement activities, including CAPA, nonconformance and internal audits.
• Contribute to Post Market Surveillance, Management Review and audit activities.

Skills

Design Controls

FDA CFR 820

ISO 13485

GxP

Excel

AI tools

Education

Bachelor's degree in Engineering

Job description

Smith+Né is seeking a Design Quality Engineer in Austin, TX to support design controls, verification and validation, and risk management for ENT products from concept through development. You will collaborate across functions to ensure products meet regulatory requirements and quality standards.

Applicants should have a Bachelor’s degree in Engineering and up to 2 years of medical device experience, with knowledge of FDA CFR 820, ISO 13485, and GxP.