Senior Product Risk Management Engineer — Medical Devices

W. L. Gore & Associates; Arizona; On-site; USD 105,000 - 140,000; Full time

Job summary

W. L. Gore & Associates seeks an experienced Product Risk Management Engineer to lead risk assessments and guide risk-based product and manufacturing development. The role supports commercial manufacturing and new product development at facilities in Flagstaff or Phoenix, Arizona.

Responsibilities include maintaining RMF and DHF files, conducting root-cause analysis, and collaborating with product, process, and design teams to ensure compliant risk management and product safety.

Qualifications

• Bachelor’s degree in engineering, science or technical field.
• Minimum 5 years’ experience with product risk management processes.
• Experience with structured problem solving (8D/8-Step/DMAIC/PDCA) and root cause analysis.

Responsibilities

• Own product line risk management files and ensure documentation meets ISO 14971 and regulatory requirements.
• Support technical investigations to address product or process issues and improve performance.
• Collaborate with engineers on process projects across development cycles (scale-up, validation, improvement).
• Work with NPD teams to ensure quality management system documentation and development planning.
• Use Risk Management File and Design History File to assess risks from design changes and events.
• Periodically review RMF documents to reflect data and ongoing activities.
• Promote risk management processes across the organization and align with global policies.

Skills

Structured problem solving

Team collaboration

Strong communication

Risk management

Root cause analysis

Education

Bachelor’s Degree in Engineering or Technical Field

Tools

Minitab

Job description

W. L. Gore & Associates seeks an experienced Product Risk Management Engineer to lead risk assessments and guide risk-based product and manufacturing development. The role supports commercial manufacturing and new product development at facilities in Flagstaff or Phoenix, Arizona.

Responsibilities include maintaining RMF and DHF files, conducting root-cause analysis, and collaborating with product, process, and design teams to ensure compliant risk management and product safety.