Design Quality Engineer III – Medical Device NPD

Boston Scientific; Austin (TX); Hybrid; USD 75,000 - 142,000; Full time

Job summary

Boston Scientific seeks a Design Quality Engineer III in Austin, TX, combining hands‑on quality engineering with cross‑functional collaboration across R&D, Regulatory Affairs and Manufacturing. You will help ensure patient safety and regulatory compliance through design controls and risk management throughout the product life cycle.

The role requires a BS in an engineering field, 3+ years of medical device experience, and the ability to work on‑site at least three days per week in a hybrid

Qualifications

• BS in Biomedical, or Mechanical Engineering, or STEM degree.
• Minimum of 3 years of medical device engineering experience.
• Working knowledge of FDA, ISO, EUMDR and medical device quality requirements.
• Understanding US and International regulations including 21 CFR 820 and EN ISO 13485/14971.

Responsibilities

• Develop, establish and maintain quality engineering methodologies for New Product Development and Sustaining activities.
• Support design reviews, risk management (DFMEA/FTA) and validation activities.
• Collaborate with R&D, Regulatory Affairs, Manufacturing and Post‑Market Surveillance.

Skills

Strong communication

Global collaboration

Troubleshooting

Education

BS in Biomedical/Mechanical/STEM

Tools

Microsoft Office

Minitab

Job description

Boston Scientific seeks a Design Quality Engineer III in Austin, TX, combining hands‑on quality engineering with cross‑functional collaboration across R&D, Regulatory Affairs and Manufacturing. You will help ensure patient safety and regulatory compliance through design controls and risk management throughout the product life cycle.

The role requires a BS in an engineering field, 3+ years of medical device experience, and the ability to work on‑site at least three days per week in a hybrid