Medical Device Design Assurance Engineer

W. L. Gore & Associates; Arizona; On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Total rewards program

Associate Stock Ownership Plan

Profit-sharing opportunities

Job summary

W. L. Gore & Associates is seeking experienced Design Assurance Engineers to join our NPD team in Flagstaff, AZ.

This hands-on role supports medical device development by applying risk management, design controls, and verification activities to ensure safety and performance. You will collaborate across functions, develop test methods, and maintain DHF traceability while navigating ambiguity and driving issues to resolution.

Qualifications

• Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and applicable experience
• Master’s Degree with applicable experience is acceptable
• Experience identifying, evaluating, and mitigating product or process risks using structured risk management
• Experience working within a regulated quality system (QMS) including design controls, investigations, or CAPA
• Experience developing, executing, or improving test methods for product/process performance
• Ability to interpret requirements and maintain bidirectional traceability across user needs, system, subystem and test

Responsibilities

• Promote an inclusive and healthy environment in alignment with Gore Culture
• Plan and execute design assurance / product quality work with leadership and cross-functional partners
• Apply design control processes to ensure products meet user needs and performance
• Develop and refine user needs, design inputs, and design outputs with clear, measurable requirements
• Develop, improve, and validate test methods for product/process performance
• Plan, support, and execute design verification and design validation activities
• Identify and mitigate product risks throughout development using risk management approaches
• Lead technical investigations to address issues and improve performance
• Ensure DHF documentation and traceability across all design history files
• Communicate technical plans and results in alignment with quality and regulatory requirements

Skills

Risk management

Design controls

Statistical methods

Traceability

Root cause analysis

Cross-functional collaboration

Communication skills

Problem solving

Independence

Travel readiness

Education

Bachelor’s degree in Engineering, Science or Technical Field

Master’s degree in Engineering, Science or Technical Field

Job description

W. L. Gore & Associates is seeking experienced Design Assurance Engineers to join our NPD team in Flagstaff, AZ.

This hands-on role supports medical device development by applying risk management, design controls, and verification activities to ensure safety and performance. You will collaborate across functions, develop test methods, and maintain DHF traceability while navigating ambiguity and driving issues to resolution.