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W. L. Gore & Associates · 15 hours ago

Process Engineer

Flagstaff, AZ

Full-time

Onsite

Entry Level

1+ years exp

W. L. Gore & Associates is seeking a Process Engineer to join their team. In this role, you will work collaboratively to refine manufacturing processes for new products and provide technical support for commercialized products in the Thoracic product family.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Provide process 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, troubleshoot non-conforming products, raw materials and components, and develop and implement corrective and preventative action (CAPA) plans

Identify and address opportunities to continuously improve our product and processes; assess for regulatory, quality, ergonomic, safety, environmental, and cost impact improvements

Drive a wide range of process projects throughout the product development lifecycle: development, scale-up, validation, and implementation

Plan and execute technical work using statistical techniques including Design of Experiments (DOE) and Statistical Process Control (SPC)

Conduct equipment and process validations, including IQ, OQ, and PQ

Qualification

Engineering degreeStructured problem-solvingStatistical techniquesLean methodologiesRegulated industry experienceTechnical communicationTeam collaborationProject management

Required

Bachelor's degree in Engineering or Science with a minimum of 1 year of hands-on engineering work experience post graduation

Experience applying structured problem-solving approaches (such as 8D, 8 step, DMAIC or PDCA) that drive root cause analysis using 5-Why, Why Trees and Fishbone analysis

Ability to effectively document, communicate, and present technical bodies of work

Ability to apply engineering fundamentals and statistical tools to develop, optimize, and troubleshoot activities

Ability to prioritize, plan, and drive projects from development to completion against agreed upon timelines/deliverables

Ability to both work independently and collaborate effectively as part of a team

Ability to travel up to 5%