Quality Engineer

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 collaboratingacross functionsandmaintainingcommunicationwith 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 experienceOR 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 approaches
• Demonstrated experience working within a regulated quality system (QMS), with exposure to areas such as design controls, investigations, or corrective and preventive action processes
• Demonstrated experience developing, executing, or improving test methods used to evaluate product or process performance
• Demonstrated ability to interpret, evaluate, and apply technical requirements, specifications, and acceptance criteria to support engineering decisions and evaluation of product performance (Demonstrated experience with bidirectional traceability - maintaining links from user need, system, subsystem and test, with full audit history)
• Demonstrated ability to analyze technical data and apply statistical methods to characterize product or process performance and support engineering decisions
• Demonstrated understanding of sampling plans and data-based decision making in a regulated environment
• Demonstrated ability to solve technical problems and make informed engineering decisions
• Demonstrated ability to work independently and collaborate effectively across functions to resolve technical challenges and drive work to completion
• Strong written and verbal communication skills, including ability to clearly document technical rationale, results, and conclusions
• Ability to travel up to 10%

• 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 5 years of applied experienceOR a Master's degree with a minimum of 4 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 minimum 7 years of applied experience OR a Master's degree with a minimum of 6 years in applied experience
• Familiarity with medical device quality system and regulatory expectations, including FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, and design control requirements.
• Relevant engineering experience in the medical device industry, including familiarity with applicable regulatory standards and quality system expectations
• Experience with design controls, risk management, and requirements management within new product development (NPD) environments