Design Quality Engineer – Medical Devices (Hybrid)

Smith & Nephew; Austin (TX); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Flexible Personal/Vacation Time Off

Paid Holidays

Health Savings Account

Job summary

Smith+Naphew in Austin is seeking a Design Quality Engineer to advance medical device development from concept to development. You will support design controls, verification and validation, sterilization and process validation, supplier qualification, and risk management to ensure products meet safety and regulatory standards.

You will partner with manufacturing and external labs, contribute to CAPA and internal audits, and help ensure compliance with FDA, ISO, MDR and GxP.

Qualifications

• Bachelor’s degree in Engineering.
• 0–2 years in the medical device or related industry.
• Understanding of Design Control and requirements such as FDA CFR 820, ISO 13485, EU MDR and GxP.
• Effective written and verbal communication skills; proficiency in Excel and AI tools.
• Ability to travel less than 5%.

Responsibilities

• Support design controls and quality activities including design verification and validation.
• Support manufacturing operations with expertise in product requirements, risk management and test methods.
• Ensure compliance with cGMP, QSR, FDA, ISO, MDR requirements.
• Partner with external laboratories and suppliers to communicate requirements and assess capabilities.
• Participate in CAPA, nonconformance and internal audit activities.
• Contribute to Post Market Surveillance and Management Review.

Skills

Communication

Project management

Teamwork

Education

Bachelor’s degree in Engineering

Tools

Excel

AI tools

Job description

Smith+Naphew in Austin is seeking a Design Quality Engineer to advance medical device development from concept to development. You will support design controls, verification and validation, sterilization and process validation, supplier qualification, and risk management to ensure products meet safety and regulatory standards.

You will partner with manufacturing and external labs, contribute to CAPA and internal audits, and help ensure compliance with FDA, ISO, MDR and GxP.