Quality Engineer

About The Role

We are looking for experienced (minimum of 3 years) or senior (minimum of 5 years) Design Assurance Engineers/Product Quality Engineers to join our New Product Development (NPD) team. In this role, you will apply your technical capabilities and problem-solving skills to define product requirements, facilitate risk management activities, develop test methods, and evaluate product performance and safety to support new medical device development.

This is a hands-on engineering role embedded in product development projects, working cross-functionally to address technical uncertainties and execute design control processes. You will be critical in ensuring medical devices are safe, effective, and meet user needs and intended uses across diverse clinical environments.

We are looking for experienced (minimum of 3 years) or senior (minimum of 5 years) Design Assurance Engineers/Product Quality Engineers to join our New Product Development (NPD) team. In this role, you will apply your technical capabilities and problem-solving skills to define product requirements, facilitate risk management activities, develop test methods, and evaluate product performance and safety to support new medical device development.

This is a hands-on engineering role embedded in product development projects, working cross-functionally to address technical uncertainties and execute design control processes. You will be critical in ensuring medical devices are safe, effective, and meet user needs and intended uses across diverse clinical environments.

This role requires the ability to independently manage work, apply risk-based thinking, and navigate ambiguity while collaborating across functions and maintaining communication with leadership.

These positions are based at our facility in Flagstaff, AZ.

• Promote an inclusive and healthy environment in alignment with the Gore Culture
• Plan and execute design assurance / product quality engineering work in collaboration with technical leadership and cross-functional partners to support new product development
• Apply design control processes throughout product development to ensure products meet user needs, intended use, and performance expectations
• Develop and refine user needs, design inputs, and design outputs, ensuring product requirements are clear, measurable, testable and traceable to support effective verification, validation, and evaluation of product performance
• Develop, improve, and validate test methods used to evaluate product or process performance, including supporting creation of new methods as required for product development
• Plan, support, and execute design verification and design validation activities to ensure product safety, effectiveness, and performance across intended use conditions
• Identify, evaluate, and mitigate product risks throughout development, including application of design and usability risk management approaches (e.g., dFMEA, uFMEA)
• Lead technical investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performance
• Ensure design control documentation and traceability meet Design History File (DHF) expectations, including linkage across user needs, design inputs, design outputs, risk controls, and verification/validation activities
• Document and communicate technical plans, experimental results, and conclusions in alignment with quality system and regulatory requirements

• For an Experienced engineering position, a Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and a minimum of 3 years of applied experience OR a Master’s degree with a minimum of 2 years in applied experience
• For a Senior engineering position, a Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals and a minimum of 5 years of applied experience OR a Master’s degree with a minimum of 4 years in applied experience
• Demonstrated experience identifying, evaluating, and mitigating product or process risks using structured risk management…