Product Risk Management Engineer

Sitka Inc.; Phoenix (AZ); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Gore is seeking an experienced Product Risk Management Engineer to lead risk assessments for product and manufacturing processes. The role focuses on risk-based decision making to ensure product safety and the maintenance of Risk Management File sections of the Design History File.

Location may be in Flagstaff or Phoenix, Arizona with a hybrid option and relocation support. Ideal candidates will drive quality improvements while collaborating with cross-functional teams to ensure regulatory

Qualifications

• Bachelor's degree required in engineering, science or technical field.
• 5+ years of experience in product risk management processes.
• Experience with structured problem-solving (8D/PDCA) for root cause analysis.
• Familiarity with global medical device regulations and standards (ISO13485, ISO14971, 21 CFR Part 803/820).

Responsibilities

• Own product line risk management files and documentation per ISO and global regulatory requirements.
• Support investigations to address product/process issues and improve performance.
• Collaborate with engineers across development cycles (scale-up, validation, improvement).
• Ensure quality management system documentation supports design and development planning.
• Assess risk from design changes, manufacturing events, and post-market surveillance.
• Periodically review Risk Management File documents to reflect data and trends.
• Promote and maintain risk management processes for medical devices globally.
• Lead changes to Risk Management Files due to standards or regulatory updates.
• Maintain consistency of Risk Management Files across product lines.
• Demonstrate equitable and inclusive behavior within the team.

Skills

Risk management

8D problem solving

Statistical analysis

Cross-functional collaboration

Communication

Travel readiness

Education

Bachelor’s degree in engineering, science or technical field

Tools

ISO 14971

ISO 13485

FDA 21 CFR Part 803/820

Job description

Category: Engineering, Scientists & Technicians

Experience Level: Experienced

Work Arrangement: Hybrid, On-site

Posting Start Date: 10/29/26

Posting End Date: 11/13/26

About the Role

We are looking for experienced Product Risk Management Engineer (PRME) to join our engineering team supporting commercial manufacturing and new product development. In this role, you will lead and facilitate risk assessments, guide risk-based product and manufacturing process development, and utilize quality system data to make risk-based decisions to ensure product safety.

The PRME contributes to the development and maintenance of compliant risk management systems, procedures and practices and is responsible for the Risk Management File portion of the product Design History File.

This position could be located at our facility in Flagstaff, or Phoenix, Arizona with the poosibility of a hybrid work arrangement. Relocation is supported.

Responsibilities

• Own product line risk management files; partner with product teams to create, manage, and maintain product risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements
• Support technical investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performance
• Partner with other engineers in a wide range of process projects throughout the development cycles: scale-up, validation, and improvement (improved safety, cost, quality, capability, and capacity)
• Partner with new product development teams to ensure appropriateness and adequacy of quality management system documentation, facilitate design and development planning and execution
• Utilize Risk Management File and Design History File documents to assess risk resulting from design and manufacturing process changes, manufacturing events and post-market surveillance
• Perform periodic review of Risk Management File documents to ensure the files remain reflective of data/trending signals and ongoing activities
• Partner with subject matter experts in the development, maintenance and promotion of risk management processes for medical devices, including management and maintenance of global policies and procedures
• Help to execute divisional changes to Risk Management Files due to changes in standards, regulations, or industry best practices
• Ensure consistency of Risk Management Files across product line
• Practice equitable and inclusive behaviors with other Associates to achieve outstanding results

Required Qualifications

• Bachelor’s Degree in Engineering, Science or Technical Field
• Minimum 5 years’ experience with product risk management processes
• Experience applying structured problem-solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives root cause analysis using 5-Why, Why Trees, and Fishbone analysis
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 803 and 820, ISO13485, ISO14971, EN 62366-1, and European Medical Device Regulations
• Knowledge of product risk management (risk identification, analysis, and mitigation methods), medical device product design and manufacturing processes
• Ability to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activities
• Ability to work effectively in team situations, building an inclusive environment, mentoring others as well as the ability to independently prioritize, initiate and drive projects from development to completion within agreed upon timelines.
• Ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making
• Strong verbal, presentation, and written communication skills
• Ability to travel up to 10%

Desired Qualifications

• Product risk management process experience in the medical device/pharmaceutical industry
• Experience with design controls, risk management, and requirements management within new product development (NPD) environments
• Strong analytical and organizational skills, flexibility, and attention to detail

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.

Copyright 2025 W. L. Gore & Associates, Inc.