Process Development Engineer - New Product Development

About the RoleWe are looking for a Process Development Engineer / Process Engineer to join our New Product Development team. In this role, you will develop, characterize, and implement manufacturing processes and equipment that enable safe, effective, scalable, and user-friendly production of new medical devices. You will work closely with design engineers, design assurance/quality partners, automation and equipment engineers, manufacturing, and cross-functional project teams to translate product and process requirements into capable manufacturing solutions. This hands‑on engineering role includes developing new processes, supporting automated or semi-automated equipment solutions, identifying and controlling critical process parameters, planning technical studies, and supporting process validation and design transfer.This position will be located at our facility in Flagstaff or Phoenix, Arizona, with the possibility of a hybrid work arrangement.ResponsibilitiesPromote an inclusive and healthy environment in alignment with the Gore CultureDevelop, characterize, and implement new or improved manufacturing processes to support new medical device development and design transferPartner with design engineering, design assurance/quality, automation/equipment engineering, manufacturing, and project teams to translate product needs into process, equipment, and manufacturing requirementsSupport development of user-friendly, safe, ergonomic, and scalable manufacturing processes and equipment, including automated or semi-automated solutions where appropriateIdentify, evaluate, and control critical process parameters and process outputs using engineering fundamentals, experimentation, statistical analysis, and risk-based thinkingPlan and execute technical studies, including process characterization, design of experiments, process capability analysis, and troubleshooting investigationsLead equipment and process validation activities, including validation planning, protocol development, IQ/OQ/PQ execution, and documentation in alignment with quality system requirementsDevelop manufacturing documentation, process specifications, work instructions, and technical reports that clearly communicate process knowledge and support future useSolve process, equipment, or manufacturing challenges using structured problem‑solving methods and data-based decision makingLead process development workstreams, manage project timelines, communicate risks and tradeoffs, and elevate issues appropriately to support project milestonesRequired QualificationsBachelor's degree in Engineering, Science, or a related technical field with 3 years of relevant engineering experience, or a Master's degree with 2 years of relevant experienceDemonstrated experience developing, improving, characterizing, or troubleshooting manufacturing processes, equipment, tooling, fixtures, or automated/semi-automated systemsDemonstrated ability to apply engineering fundamentals and statistical methods to evaluate process performance and make data-based decisionsDemonstrated experience planning and executing technical studies, experiments, or process characterization workDemonstrated ability to identify process risks, failure modes, critical process parameters, or key process outputs and apply risk-based thinking to drive decisionsDemonstrated experience working within a regulated quality system or highly controlled manufacturing environmentDemonstrated ability to collaborate across functions such as design engineering, quality, manufacturing, automation/equipment engineering, maintenance, or supply chainDemonstrated ability to independently manage medium-scale work, establish realistic timelines, communicate progress, and drive work to completionStrong written and verbal communication skills, including the ability to document technical rationale, results, conclusions, and recommendationsAbility to travel up to 15%#J-18808-Ljbffr