Process Engineer

About the Role

We are looking for an experienced Process Engineer to join our engineering team supporting commercial manufacturing. In this role, you will work in a dynamic, cross-functional environment focused on sustaining and improving manufacturing processes, equipment, product quality, operational stability, efficiency, and scalability.

This role will support the Gore Component Technologies team located at our facility in Flagstaff, AZ with the possibility of a hybrid work arrangement.

Responsibilities

• Provide day-to-day process support for the manufacturing lines of existing products, including maintaining manufacturing fixtures, equipment, and standard operating procedures, with a strong presence on the manufacturing floor. Support transition of new products and processes into production. Manufacturing support may require flexibility outside of standard working hours.
• Ensure manufacturing processes meet performance targets by identifying opportunities and implementing improvements to safety, quality, efficiency, cost, and capability. Utilize Lean manufacturing principles, good manufacturing practices (GMP), and structured problem solving methodologies to eliminate waste and variation.
• Specify, design, implement and improve manufacturing processes required to support the process.
• Understand critical process parameters for equipment and process to ensure the process reliably delivers a fit for use product that meets all specifications and customer requirements.
• Effectively collaborate and influence cross-functionally with Quality Assurance, Operations, and Technical to drive solutions and sustain performance.
• Lead a range of projects from concept through implementation. Plan, create, and manage a work breakdown structure and timeline while communicating status to stakeholders and escalating challenges when appropriate.
• Apply formal problem-solving techniques to determine root cause of equipment, process, and product related issues and non-conformances. Identify, implement and sustain effective and timely countermeasures.
• Conduct equipment and process validations, qualifications, and verifications that meet production and regulatory requirements.
• Document technical work clearly and communicate effectively to team and cross-functional partners.

Required Qualifications

• Bachelor’s degree in engineering or science with a minimum of 2 years of professional engineering experience supporting a manufacturing environment
• Experience applying engineering fundamentals to develop, optimize, troubleshoot, and control products, processes, or technologies. With support, ability to design experiments, analyze data, understand system interactions, and use structured approaches such as experimentation, validation, process control, statistical analysis or root cause analysis to drive decisions and improvements
• Demonstrated experience independently leading engineering projects within a defined area of responsibility, such as a manufacturing process, equipment system, product line, or operational workstream (Projects typically involve coordination within a team and delivery of measurable improvements in safety, quality, delivery, or cost)
• Demonstrated ability to prioritize, plan, and execute multiple projects concurrently from concept to completion utilizing industry standard project management tools to deliver results against agreed upon timelines and deliverables
• Demonstrated ability to leverage critical thinking to identify critical issues and failure modes utilizing structured problem solving approaches to define the problem and identify root cause
• Demonstrated ability to work independently and effectively collaborate in an inclusive environment with cross-functional teams
• Demonstrated ability to document, communicate, and present technical bodies of work
• Ability to work hands-on in a cleanroom environment
• Ability to travel up to 5% of the time

Desired Qualifications

• Experience in a regulated manufacturing environment (e.g., medical device, pharmaceutical, aerospace, or similar)
• Applied experience using Lean, Six Sigma, or other similar methodologies for process improvement
• Demonstrated ability to make risk-based decisions, such as the use of FMEA, FTA, contingency planning for making proposals

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.