Product Risk Management Engineer

W.L. Gore & Associates, Inc.
remote work
United States, Arizona, Flagstaff
Mar 07, 2025
About the Role: We are seeking a Product Risk Management Engineer (PRME) to join a high performing team who will be accountable for risk management activities throughout the life cycle of the product. This team works well independently and collaboratively to drive the appropriate activities such as leading and facilitating risk assessments, guiding risk-based product and manufacturing process development, and utilizing quality system data to make risk-based decisions to ensure product safety. The PRME contributes to 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 is a remote position, and you can work from home in most locations within the United States. Responsibilities: Own the 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 Provide guidance and support to design and manufacturing teams in the generation of risk management documentation, e.g., HHA, dFMEA, pFMEA, uFMEA, Fault Tree Analysis, etc Support the development of risk-based test plans 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 reviews 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 maintainance 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 lines Required Qualifications: Bachelor's degree in business, technical, or scientific field A minimum of 5 years' experience with product risk management processes (medical device/pharmaceutical industry preferred) Successful experience working independently and on cross-functional teams Strong computer literacy (MS Word, Excel, PowerPoint) Strong analytical and organizational skills, flexibility, and attention to detail Strong verbal, presentation, and written communication skills Ability to travel up to 10% Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803 and 820, ISO13485, ISO14971, EN 62366-1, and European Medical Device Regulations Knowledge of medical device product design and manufacturing processes Remote Working Arrangements arepermitted forAssociates in the continentalUnited States (US) andCanada, withappropriate approval and compliancewithGore's remote working policies, from thecountryin which they are employed. For fully remote roles, thefollowing locations are not eligiblefornew fully remote workarrangements: Alaska andHawaii (forall roles), and Rhode Island(forwage/hourly roles only). What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow. We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect. Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations. Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws. Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description. Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact