Senior Process Engineer – Manufacturing Integration & Process Transfer

GE Healthcare GE Healthcare · Healthcare · State College, PA +1 · Engineering / Technology

This role focuses on manufacturing process engineering for ultrasound transducer programs, ensuring they meet quality, regulatory, cost, and delivery requirements during transfer from R&D to production. It involves leading continuous improvement, developing documentation, and understanding materials and fixture design.

What you'd actually do

  1. Provide manufacturing engineering support for the transfer of processes from R&D into full production.
  2. Apply and improve standard manufacturing approaches to ensure robust, capable production processes.
  3. Support quality and regulatory compliance during product introduction, including coordination of process and equipment qualification activities.
  4. Serve as a technical liaison with Quality to ensure requirements are met and documentation is complete and compliant.
  5. Interface with Purchasing and suppliers to define and clarify incoming material technical requirements.

Skills

Required

  • Bachelor's degree in an Engineering or Science discipline
  • Minimum 5 years’ experience in a manufacturing environment

Nice to have

  • Experience in a FDA, ISO13485, or other highly regulated environment
  • Master’s degree in an Engineering or Science discipline
  • Working knowledge of ERP systems (e.g., Visual, Oracle, SAP) and electronic Device History Record (eDHR) systems
  • Experience in medical device manufacturing, preferably ultrasound transducers
  • Experience with process risk evaluation and mitigation techniques, including pFMEA
  • Proficiency in data analysis, including statistical methods and visualization
  • Demonstrated project management skills

What the JD emphasized

  • highly regulated environment