Product Risk Management Engineer

About the RoleWe 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, or Phoenix, Arizona with the poosibility of a hybrid work arrangement. Relocation is supported. ResponsibilitiesOwn 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 requirementsSupport technical investigations and problem-solving efforts to address product or process issues, resolve technical uncertainties, and improve product performancePartner 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 executionUtilize Risk Management File and Design History File documents to assess risk resulting from design and manufacturing process changes, manufacturing events and post-market surveillancePerform periodic review of Risk Management File documents to ensure the files remain reflective of data/trending signals and ongoing activitiesPartner 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 proceduresHelp to execute divisional changes to Risk Management Files due to changes in standards, regulations, or industry best practicesEnsure consistency of Risk Management Files across product linePractice equitable and inclusive behaviors with other Associates to achieve outstanding resultsRequired QualificationsBachelor’s Degree in Engineering, Science or Technical FieldMinimum 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 analysisWorking 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 RegulationsKnowledge of product risk management (risk identification, analysis, and mitigation methods), medical device product design and manufacturing processesAbility to apply engineering fundamentals and statistical analysis to product quality support, optimization, and troubleshooting activitiesAbility 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 makingStrong verbal, presentation, and written communication skillsAbility to travel up to 10%Desired QualificationsProduct risk management process experience in the medical device/pharmaceutical industryExperience with design controls, risk management, and requirements management within new product development (NPD) environmentsStrong analytical and organizational skills, flexibility, and attention to detailWhat We OfferOur 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/benefitsGore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to 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 protected 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 United States. Gore generally will not sponsor visas unless otherwise noted on the position description.