About the Role

We are looking for an experienced Design Assurance Engineer / Product Quality Engineer 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, develop test methods, and evaluate product performance to support the development of new medical devices.

This is a hands-on engineering role embedded in product development, focused on requirements elicitation and decomposition, test method development, product risk identification and mitigation, and execution of design control processes. You will work cross-functionally to address technical uncertainties, contribute to verification and validation activities, and ensure product performance and safety across intended use conditions. This role plays a critical part in ensuring medical devices are safe, effective, and meet user needs and intended use across diverse clinical environments. This role requires the ability to independently manage work, apply risk-based thinking, and navigate ambiguity while collaborating across functions.

This role is based in either Flagstaff or Phoenix, Arizona.

Responsibilities

• 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
• Support development and refinement of user needs, design inputs, and design outputs to enable clear definition 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

Required Qualifications

• Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge of engineering fundamentals with minimum of 3 years of relevant engineering experience, or a Master’s Degree with minimum of 2 years of relevant experience
• Demonstrated ability to analyze technical data and apply statistical methods to characterize product or process performance and support engineering decisions
• 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 ability to evaluate whether products or processes meet defined requirements, specifications, or performance expectations
• Demonstrated experience developing, executing, or improving test methods used to evaluate product or process performance
• 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%

Desired Qualifications

• Minimum 5 years of relevant engineering experience
• Experience in the medical device industry, including familiarity with applicable regulatory standards and quality system expectations (e.g., FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971)
• Experience with design controls, risk management, and requirements management within new product development (NPD) environments