Quality Engineer

Sitka Inc.; Flagstaff (AZ); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stock Ownership Plan

Profit-sharing

Job summary

Gore is seeking experienced Design Assurance Engineers to join our New Product Development team in Flagstaff, AZ. You will apply design controls, risk management, and test method development to support medical device development and ensure safety and effectiveness across use environments.

This hands‑on role collaborates across functions and leadership to navigate ambiguity, manage design history file expectations, and drive product performance improvements. Travel up to 10% may be required.

Qualifications

• Experience applying design controls in medical device development.
• Proven ability to identify, assess, and mitigate risks.
• Ability to develop and validate test methods and support verification/validation.

Responsibilities

• Promote an inclusive and healthy work environment.
• Plan and execute design assurance and quality activities for new product development.
• Apply design controls to ensure user needs and performance are met.
• Develop, refine, and trace user needs, inputs, outputs, and risk controls.
• Develop and validate test methods for product/process performance.
• Plan and execute verification and validation activities for safety and effectiveness.
• Identify and mitigate product risks across development.
• Lead investigations and resolve technical uncertainties.
• Maintain DHF documentation and traceability.

Skills

Design controls

Risk management

Test method development

Statistical analysis

Cross-functional collaboration

Technical communication

Education

Bachelors in Engineering/Science

Master's degree (preferred)

Tools

Quality Management System (QMS)

Job description

Category: Engineering, Scientists & Technicians

Work Arrangement: Hybrid

Posting Start Date: 7/29/26

Posting End Date: 10/30/26

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.

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.

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
• 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

Required Qualifications

• 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 experienceOR 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%

Desired Qualifications

• 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 experienceOR 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

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well‑being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit‑sharing”. Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug‑free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.

For over 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

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