Hybrid Product Risk Management Engineer (Medical Devices)

W. L. Gore & Associates; Arizona; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Stock Ownership Plan

Relocation assistance

Competitive benefits package

Job summary

W. L. Gore & Associates seeks an experienced Product Risk Management Engineer to lead risk assessments and guide risk-based product and process development for medical devices.

You will manage RMF and DHF documents, align with ISO 14971, ISO 13485, and regulatory requirements, and support product safety across manufacturing and new product development. The role offers hybrid work in Arizona with relocation support, and requires strong problem-solving, communication, and collaboration skills to

Qualifications

• Bachelor’s Degree in Engineering, Science or Technical Field.
• 5+ years’ experience with product risk management processes.
• Experience applying structured problem-solving (8D, 8-Step, DMAIC or PDCA) with 5-Why, Why Trees, and Fishbone analysis.
• Knowledge of global medical device regulations and standards such as 21 CFR 803/820, ISO13485, ISO14971, EN 62366-1, and European Medical Device Regulations
• Strong communication skills and ability to travel up to 10%.

Responsibilities

• Own product line risk management files per ISO and regulatory requirements.
• Support investigations and problem-solving to address product/process issues.
• Partner with engineers across development cycles: scale-up, validation, improvement.
• Ensure quality management system documentation adequacy for NPD.
• Use RMF and DHF to assess risks from design/manufacturing changes.
• Perform periodic reviews of RMF documents.
• Promote risk management processes across the organization.
• Execute divisional changes to RMF due to standards/regulations.
• Ensure RMF consistency across product lines.
• Practice inclusive behaviors to drive results.

Skills

Structured problem solving

Root cause analysis

Team collaboration

Verbal & written communication

Risk management

Travel readiness

Education

Bachelor’s Degree in Engineering, Science or Technical Field

Tools

ISO13485 knowledge

21 CFR Part 803/820

RMF/DHF familiarity

Design Controls

Job description

W. L. Gore & Associates seeks an experienced Product Risk Management Engineer to lead risk assessments and guide risk-based product and process development for medical devices.

You will manage RMF and DHF documents, align with ISO 14971, ISO 13485, and regulatory requirements, and support product safety across manufacturing and new product development. The role offers hybrid work in Arizona with relocation support, and requires strong problem-solving, communication, and collaboration skills to