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.

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 escalate 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%