Senior Process Engineer
About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore/products/industries About the Role: Are you a Senior Process Engineer looking for a collaborative work environment where your unique contributions will help manufacture products that improve life? We are looking for a Senior Process Engineer to join various teams in our Medical Products Division and Core Technology Division. As a Process Engineer you can contribute to many areas of a product’s lifecycle, which may include Manufacturing, Product Development, or a Technology Platform. This position offers the option to work on-site at a facility in Phoenix or Flagstaff, Arizona, with flexible work from home options available. This position may be eligible for a hybrid work arrangement, meaning you could work remote part of the time, depending upon the responsibilities of the role and business needs* Responsibilities: Provide process design and support for the manufacturing of new and existing products Understand critical process parameters to ensure the process reliably delivers a fit for use product that meets all specifications and customer requirements Apply formal problem-solving techniques to determine root cause, troubleshooting non-conforming products, raw materials, and components, and developing and implementing corrective and preventative action (CAPA) plans Identify and address opportunities to continuously improve our products and processes; and assess for regulatory, quality, ergonomic, safety, environmental, and cost impact Drive a wide range of process projects throughout the development cycle: development, scale-up, validation, and improvement Plan and execute technical work using statistical techniques including Design of Experiments (DoE) and Statistical Process Control (SPC) Required Qualifications: Bachelor’s Degree in Engineering or Science with a minimum of 5 years of hands-on engineering experience Proven history of documenting and communicating work effectively Demonstrated ability to apply structured problem solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives root cause analysis using 5-Why, Why Trees, and Fishbone analysis Demonstrated ability to apply engineering fundamentals and statistical tools to development, optimization, and troubleshooting activities Demonstrated ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables Demonstrated ability to work independently and collaborate effectively as part of a team, including influencing across functions Demonstrated ability to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause including effective risk-based decision making Ability to travel up 10% Desired Qualifications: Experience in a Regulated Industry Experience coaching or mentoring Experience with quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc.) *Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).