Product Risk Management Engineer

W. L. Gore & Associates, Inc.; Phoenix (AZ); On-site; USD 110,000 - 150,000; Full time

Job summary

W. L. Gore & Associates, Inc. is seeking an experienced Product Risk Management Engineer to lead risk assessments and guide risk-based product and manufacturing process development. You will ensure compliant risk management systems and manage the Risk Management File portion of the DHF.

The role involves coordinating with product teams, supporting investigations, and applying risk-based decisions to enhance product safety and quality. Location options include Flagstaff or Phoenix campuses.

Qualifications

• Bachelor's Degree in Engineering, Science or Technical Field required.
• Minimum 5 years' experience with product risk management processes.
• Experience applying structured problem-solving approaches (8D, 8-Step, DMAIC or PDCA).
• Knowledge of global medical device regulations and standards (e.g., 21 CFR Part 803/820, ISO13485, ISO14971, EN 62366-1).
• Ability to apply engineering fundamentals and statistical analysis to product quality support.
• Strong communication and teamwork with ability to drive projects end-to-end.

Responsibilities

• Own product line risk management files and documentation (ISO 14971, regulatory requirements).
• Support investigations to address product/process issues and improve performance.
• Collaborate with engineers across development cycles (scale-up, validation, improvement).
• Ensure adequacy of quality management system documentation for NPD.
• Use RMF and DHF documents to assess risk from design/manufacturing changes.

Skills

Risk management

Structured problem solving

Root cause analysis

Team collaboration

Communication skills

Travel up to 10%

Education

Bachelor's Degree in Engineering, Science or Technical Field

Tools

Quality systems data

ISO 13485/14971 awareness

21 CFR Part 803/820 familiarity

Job description

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, Arizona or Phoenix, Arizona.

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