Medical Device Risk Architect & Quality 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

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.