Senior Product Risk Engineer (Medical Devices) – Hybrid

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 110,000 - 160,000; Full time

Job summary

W. L. Gore & Associates, Inc.

is seeking an experienced Product Risk Management Engineer to lead risk assessments for commercial manufacturing and new product development. You will guide risk-based product and process development and use quality data to drive risk-based decisions ensuring product safety. The role supports Risk Management File development, is located at our Flagstaff or Phoenix facilities with hybrid work options, and offers relocation assistance.

Qualifications

• Bachelor's degree in engineering/science/technical field.
• Minimum 5 years' experience with product risk management processes.
• Experience with structured problem-solving (8D/8- Step/DMAIC/PDCA) driving root cause analysis.
• Knowledge of global medical device regulations (e.g., 21 CFR 803/820, ISO13485, ISO14971).
• Experience applying risk management, design controls, and manufacturing processes.
• Strong teamwork, communication, and ability to prioritize and drive projects.

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 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

Skills

Risk management

Root cause analysis

Structured problem solving

Quality systems knowledge

Regulatory knowledge

Communication skills

Cross-functional collaboration

Planning and prioritization

Education

Bachelor's Degree in Engineering, Science or Technical Field

Job description

W. L. Gore & Associates, Inc.

is seeking an experienced Product Risk Management Engineer to lead risk assessments for commercial manufacturing and new product development. You will guide risk-based product and process development and use quality data to drive risk-based decisions ensuring product safety. The role supports Risk Management File development, is located at our Flagstaff or Phoenix facilities with hybrid work options, and offers relocation assistance.