Process Engineer

Req Id: 1760

State/Province: Arizona

Business: Gore Medical Products

Category: Engineering, Scientists & Technicians

Sub-Category: Engineering

Work Arrangement: Hybrid

Posting Start Date: 6/4/26

Posting End Date: 6/19/26

About the Role

The Catheter Bonding and Stent Transfer Capabilities Teams are seeking highly experienced Process Engineers to lead the development, optimization, and commercialization of advanced catheter bonding and/or stent transfer processes. In this senior technical role, you will apply deep engineering expertise, strategic thinking, and cross-functional influence to shape manufacturing capabilities, drive process innovation, and ensure robust, scalable solutions for both new product development and commercialized product lines.

This position may be based at our Phoenix, Arizona or Flagstaff, Arizona facility.

Responsibilities

• Provide expert-level support for manufacturing of new and existing catheter and/or stent products, ensuring stable, capable, and compliant processes
• Partner with NPD, MFG, Quality, Manufacturing, Supply Chain, and Equipment Engineering to define and execute project schedules for process development, validation, and commercialization of catheter and/or stent transfer processes
• Identify, characterize, and control critical process parameters for catheter bonding applications to ensure reliable delivery of products meeting all specifications and customer requirements
• Specify, procure, and implement new equipment designs; lead process development and validation activities for new technologies and bonding and/or transfer methods
• Identify technical uncertainties, apply engineering fundamentals, and drive resolution of complex technical challenges using structured methodologies
• Lead initiatives to improve product quality, process capability, ergonomics, safety, environmental impact, and cost of catheter/stent products and processes
• Plan and execute technical studies using statistical tools such as DoE, SPC, and capability analysis
• Lead equipment and process validations (IQ/OQ/PQ), ensuring compliance with regulatory and quality system requirements
• Apply formal problem-solving techniques to investigate nonconformances, raw material issues, and component failures; develop and implement corrective and preventive actions
• Drive process development projects from concept through scale-up, validation, and full implementation into manufacturing

Required Qualifications

• Bachelor's degree in Engineering or Science (Chemical, Mechanical, Materials, or related field) with minimum of 8 years of hands-on experience supporting new product development or manufacturing
• Demonstrated expertise applying structured problem-solving approaches such as 8D, DMAIC, PDCA, 5-Why, Why Trees, and Fishbone analysis
• Proficiency with statistical tools, DoE, validation methodologies, and lean manufacturing principles
• Strong ability to document, communicate, and present complex technical work to diverse audiences
• Proven capability to apply engineering fundamentals and statistical tools to develop, optimize, and troubleshoot processes
• Demonstrated ability to prioritize, plan, and execute projects from development through completion
• Ability to identify critical issues and failure modes, perform risk-based decision making, and drive resolution
• Strong collaboration and influencing skills across engineering, maintenance, quality, and manufacturing
• Ability to travel up to 15%

Desired Qualifications

• Lean Six Sigma certification or equivalent experience applying Lean methodologies.
• Experience in catheter bonding and polymer processing and/or medical stent graft process development and processing.
• Experience influencing and collaborating with cross-functional teams through strong verbal and written communication.
• Experience working in a regulated industry with established quality systems, documentation requirements, and compliance expectations.

What We Offer

Our 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/benefits

Information at a Glance