Medical Device Design Assurance Engineer

W. L. Gore & Associates, Inc.; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

W. L. Gore & Associates, Inc.

in Phoenix, AZ, is seeking experienced Design Assurance/Product Quality Engineers for our New Product Development (NPD) team. This hands-on role will apply technical capabilities to define requirements, drive risk management, develop test methods, and evaluate product performance to support medical device development. Senior and experienced roles require 3–5+ years in relevant fields; candidates should hold a engineering degree.

Qualifications

• Bachelor's degree with 3+ years of applied engineering experience, or Master's with 2+ years.
• Senior position requires 5+ years or Master's with 4+ years.
• Experience in risk management within regulated quality systems (QMS) and familiarity with FDA 21 CFR 820 / ISO standards.
• Experience developing, executing, or improving test methods for product/process performance.
• Strong ability to interpret requirements and maintain bidirectional traceability across user needs, inputs, outputs, and tests.

Responsibilities

• Plan and execute design assurance / product quality work to support new product development.
• Apply design controls to ensure user needs, use, and performance are met.
• Develop, refine, and validate test methods for product and process performance.
• Plan and execute verification and validation activities to ensure safety and effectiveness.
• Identify, evaluate, and mitigate product risks; lead technical investigations.

Skills

Design controls

Risk management

Verification & validation

Statistical methods

Technical communication

Cross-functional collaboration

Travel readiness

Education

Bachelor's/Master's in Engineering/Science/Technical Field

Job description

W. L. Gore & Associates, Inc.

in Phoenix, AZ, is seeking experienced Design Assurance/Product Quality Engineers for our New Product Development (NPD) team. This hands-on role will apply technical capabilities to define requirements, drive risk management, develop test methods, and evaluate product performance to support medical device development. Senior and experienced roles require 3–5+ years in relevant fields; candidates should hold a engineering degree.