Process Engineer

About the Role

Research & Development is currently seeking Process Engineers to support the development, optimization, and commercialization of new medical devices and commercialization of advanced process technologies. In this experienced technical role, you will apply engineering expertise, strategic thinking, and cross-functional influence to drive process innovation, shape manufacturing capabilities of medical devices to meet long term business requirements, and ensure robust, scalable solutions for new product and/or equipment development.

This posting includes opportunities to support the following teams: Thermal Capabilities, Crush/Load Capabilities, Wrap/Laser Capabilities, Aortic NPD, and Peripheral NPD.

These positions will be located in our Phoenix, Arizona facility.

Responsibilities

• Provide senior-level process engineering support for new and existing medical device manufacturing processes, ensuring stable, capable, compliant, and scalable operations.
• Embrace a mindset of continuous learning by challenging assumptions, exploring new approaches, and actively seeking opportunities to grow and innovate.
• Collaborate with multiple functions to establish and execute project schedules for process/technology development, validation and commercialization activities.
• Specify, evaluate, select, implement, and commission new equipment, tooling, fixtures, and emerging process capabilities as required to support project success.
• Identify technical uncertainties, apply engineering fundamentals, and drive resolution of complex technical challenges using structured methodologies to control critical process parameters and key process inputs to ensure products meet specifications, customer requirements, and quality system expectations.
• Plan, prototype, and execute structured technical studies using engineering fundamentals and statistical tools such as design of experiments, statistical process control, capability analysis, and process characterization.
• Lead or support process validation activities, including IQ, OQ, POQ, SQA, process characterization, and related documentation, ensuring compliance with regulatory and quality system requirements.
• Document technical work clearly and communicate insights, risks, recommendations, decisions, and project status to cross-functional partners, manufacturing teams, and technical leadership by utilizing Gore project practices and lean business tools to effectively prioritize, plan, and drive projects from development to completion.
• Support initiatives to improve product quality, process/technology capability, ergonomics, safety, environmental impact, and financial metrics for R&D projects and process improvements.
• Effectively collaborate and influence cross-functional teams including product specialists, supply chain, manufacturing, regulatory, quality, and external partners.

Required Qualifications

• Bachelor’s or advanced degree in engineering or science, such as Chemical, Mechanical, Materials, or a related discipline, with a minimum of 5 years of hands-on experience supporting new product development or manufacturing.
• Demonstrated expertise applying structured problem-solving approaches, including 8D, DMAIC, PDCA, 5 Why, Why Trees, and Fishbone analysis.
• Advanced or expert knowledge of process or technology development, manufacturing scalability, and the strategic application of regulatory requirements.
• Experience leading medium- to large-scale initiatives involving a process domain, project teams, or manufacturing lines, including resolving systemic issues affecting those teams or operations.
• Ability to define and execute project management strategies that accelerate timelines from established baselines and drive decision-making through refined business proposals presented to local or business group leadership.
• Experience solving underdefined and challenging problems by applying established approaches and solutions while evaluating cross-functional impacts to products and processes.
• Experience coaching and reviewing the work of local team members while contributing subject-matter expertise to the development of operational strategies.
• Demonstrated ability to independently prioritize, plan, and execute projects from development through completion while collaborating effectively and influencing across engineering, maintenance, quality, manufacturing, and other functions.
• Experience supporting equipment validations, process qualifications, commissioning activities, and the implementation of new manufacturing capabilities.
• Ability to travel up to 25% as needed to support project execution, equipment implementation, process development, validation, and manufacturing support activities. Travel requirements may vary by team and location.

Desired Qualifications

• Lean Six Sigma certification or equivalent experience applying Lean methodologies.
• Background in prototyping mechanical or electromechanical systems, including interpreting engineering drawings and requirements.
• Minimum 3 years in new product development, manufacturing, or relevant process technology areas (i.e., thermal processing, crush/loading of medical devices, wrap processes, laser processing, or stent graft process development) & experience throughout the full design control process.