Product Risk Management Engineer

W. L. Gore & Associates; Arizona; On-site; USD 110,000 - 150,000; Full time

Job summary

W. L. Gore & Associates in the United States is seeking an experienced Product Risk Management Engineer (PRME) to lead risk assessments and guide risk-based product and process development for medical devices.

This role focuses on maintaining compliant risk management systems, contributing to the Risk Management File portion of the Design History File, and collaborating with cross-functional teams across development cycles. This position could be located at our Flagstaff or Phoenix locations.

Qualifications

• Minimum 5 years’ experience with product risk management processes.
• Experience applying structured problem-solving approaches (8D, 8-Step, DMAIC or PDCA).
• Working knowledge of global medical device regulations and standards (e.g., 21 CFR 803/820, ISO13485, ISO14971).
• Knowledge of risk management methods in medical device design and manufacturing.
• Strong communication skills, both written and verbal.
• Willingness to travel up to 10%.

Responsibilities

• Own product line risk management files; partner with product teams to create, manage, and maintain documentation in accordance with ISO 14971 and global regulatory requirements.
• Support investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performance.
• Partner with engineers across development cycles: scale-up, validation, and improvement to enhance safety, cost, quality, capability, and capacity.
• Collaborate with new product development teams to ensure QA documentation, planning and execution.
• Utilize Risk Management File and Design History File to assess risk from design/manufacturing changes and post-market surveillance.
• Perform periodic review of Risk Management File documents to reflect data/trending signals and ongoing activities.
• Work with SMEs to develop and promote risk management processes and global policies.
• Help execute divisional changes to Risk Management Files due to standards or regulations.
• Ensure consistency of Risk Management Files across product lines.
• Practice equitable and inclusive behaviors to achieve outstanding results.

Skills

Product risk management

ISO 14971

Quality systems

8D / DMAIC

Regulatory compliance

Statistical analysis

Communication skills

Travel up to 10%

Education

Bachelor’s Degree in Engineering, Science or Technical Field

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