Process Development Engineer - New Product Development

About the Role We 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. Responsibilities Promote an inclusive and healthy environment in alignment with the Gore Culture Develop, characterize, and implement new or improved manufacturing processes to support new medical device development and design transfer Partner with design engineering, design assurance/quality, automation/equipment engineering, manufacturing, and project teams to translate product needs into process, equipment, and manufacturing requirements Support development of user-friendly, safe, ergonomic, and scalable manufacturing processes and equipment, including automated or semi-automated solutions where appropriate Identify, evaluate, and control critical process parameters and process outputs using engineering fundamentals, experimentation, statistical analysis, and risk-based thinking Plan and execute technical studies, including process characterization, design of experiments, process capability analysis, and troubleshooting investigations Lead equipment and process validation activities, including validation planning, protocol development, IQ/OQ/PQ execution, and documentation in alignment with quality system requirements Develop manufacturing documentation, process specifications, work instructions, and technical reports that clearly communicate process knowledge and support future use Solve process, equipment, or manufacturing challenges using structured problem‑solving methods and data-based decision making Lead process development workstreams, manage project timelines, communicate risks and tradeoffs, and elevate issues appropriately to support project milestones Required Qualifications Bachelor’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 experience Demonstrated experience developing, improving, characterizing, or troubleshooting manufacturing processes, equipment, tooling, fixtures, or automated/semi-automated systems Demonstrated ability to apply engineering fundamentals and statistical methods to evaluate process performance and make data-based decisions Demonstrated experience planning and executing technical studies, experiments, or process characterization work Demonstrated ability to identify process risks, failure modes, critical process parameters, or key process outputs and apply risk-based thinking to drive decisions Demonstrated experience working within a regulated quality system or highly controlled manufacturing environment Demonstrated ability to collaborate across functions such as design engineering, quality, manufacturing, automation/equipment engineering, maintenance, or supply chain Demonstrated ability to independently manage medium-scale work, establish realistic timelines, communicate progress, and drive work to completion Strong written and verbal communication skills, including the ability to document technical rationale, results, conclusions, and recommendations Ability to travel up to 15% #J-18808-Ljbffr W. L. Gore & Associates, Inc.