Design Assurance Engineer – Medical Devices (NPD)

wlgore; Flagstaff (AZ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Stock Ownership Plan

Profit-sharing

Benefits package

Job summary

Gore is seeking an experienced Design Assurance Engineer to join our New Product Development team in Flagstaff, AZ. You will apply risk-based thinking to define product requirements, facilitate design controls, and evaluate product performance to support new medical device development.

This is a hands-on role embedded in product development projects, requiring cross-functional collaboration, independent work, and clear communication with leadership. Travel up to 10% may be required.

Qualifications

• Bachelor’s or Master’s degree with relevant engineering fundamentals and applied experience
• Minimum 3 years (experienced) or 5 years (senior) of applied experience in design assurance or product quality
• Experience identifying, evaluating, and mitigating product/process risks using structured risk management
• Experience working within a regulated quality system (QMS) including design controls and CAPA processes
• Experience developing, executing, or improving test methods for product/process performance
• Ability to interpret requirements and establish traceability from user needs to tests with audit history
• Ability to analyze data, apply statistics, and support engineering decisions
• Ability to work independently and collaborate across functions to resolve challenges
• Strong written and verbal communication skills; travel up to 10%

Responsibilities

• Promote Gore culture and inclusive environment
• Plan and execute design assurance/quality work to support new product development
• Apply design control processes to meet user needs and performance expectations
• Develop, refine, and trace user needs, design inputs/outputs for verification and validation
• Develop and validate test methods for product performance
• Plan and execute design verification and validation across use conditions
• Identify and mitigate product risks throughout development (dfMEA, ufMEA)
• Lead investigations to resolve issues and improve product performance
• Ensure DHF traceability across needs, inputs, outputs, risk controls, and tests
• Document and communicate technical results in line with quality/regulatory requirements

Skills

Design Assurance

Quality Engineering

Risk Management

Statistical Methods

Cross-functional Collaboration

Communication

Travel willingness

Education

Bachelor’s degree in Engineering/Science/Technical Field

Master’s degree in Engineering/Science

Job description

Gore is seeking an experienced Design Assurance Engineer to join our New Product Development team in Flagstaff, AZ. You will apply risk-based thinking to define product requirements, facilitate design controls, and evaluate product performance to support new medical device development.

This is a hands-on role embedded in product development projects, requiring cross-functional collaboration, independent work, and clear communication with leadership. Travel up to 10% may be required.