Process Development Engineer - New Product Development

W. L. Gore & Associates
Flagstaff, AZ
Category Engineering
Job Description
Role Overview

We are looking for a Process Development Engineer to join our New Product Development team. In this role, you will develop, characterize, and implement manufacturing processes and equipment that enable safe, effective, scalable, and user-friendly production of new medical devices.

What You Will Do

Develop, characterize, and implement new or improved manufacturing processes to support new medical device development and design transfer. Partner with design engineering, design assurance/quality, automation/equipment engineering, manufacturing, and project teams to translate product needs into process, equipment, and manufacturing requirements.

Why It Might Be a Fit

This hands-on engineering role includes developing new processes, supporting automated or semi-automated equipment solutions, identifying and controlling critical process parameters, planning technical studies, and supporting process validation and design transfer.

Requirements

  • Bachelor's degree in Engineering, Science, or a related technical field
  • 3+ years of relevant engineering experience
  • Demonstrated experience developing, improving, characterizing, or troubleshooting manufacturing processes, equipment, tooling, fixtures, or automated/semi-automated systems
  • Demonstrated ability to apply engineering fundamentals and statistical methods to evaluate process performance and make data-based decisions
  • Demonstrated experience planning and executing technical studies, experiments, or process characterization work
  • Demonstrated ability to identify process risks, failure modes, critical process parameters, or key process outputs and apply risk-based thinking to drive decisions
  • Demonstrated experience working within a regulated quality system or highly controlled manufacturing environment
  • Demonstrated ability to collaborate across functions such as design engineering, quality, manufacturing, automation/equipment engineering, maintenance, or supply chain
  • Demonstrated ability to independently manage medium-scale work, establish realistic timelines, communicate progress, and drive work to completion
  • Strong written and verbal communication skills

Benefits

  • hybrid work arrangement
  • opportunity to work in a regulated quality system or highly controlled manufacturing environment
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