Senior Process Engineer

Baltgroup

Irvine, CA, United States
On-site
Class ii or iii implantable medical devices
Polymer extrusion and thermal bonding processes
Fda qsr and cgmp regulatory compliance
Baltgroup is seeking a Senior Process Engineer in Irvine, CA, to enhance manufacturing processes for neurovascular medical devices. The role requires a strong background in the medical device industry, particularly with Class II and III devices

Job Summary

  • The role involves supporting the continuous improvement of manufacturing processes for neurovascular medical devices that save patient lives.
  • Candidates will be responsible for design transfer, commercialization of new products, and optimizing existing production operations.
  • Balt offers a passionate team environment where pride in work and recognition are key aspects of the employee experience.

Matching Summary

Match Score: 85

Baltgroup is seeking a Senior Process Engineer in Irvine, CA, to enhance manufacturing processes for neurovascular medical devices. The role requires a strong background in the medical device industry, particularly with Class II and III devices.

Skills & Requirements

Must-have

  • Class II or III implantable medical devices
  • Polymer extrusion and thermal bonding processes
  • FDA QSR and cGMP regulatory compliance
  • IQ OQ PQ process validation execution
  • Statistical Process Control and Design of Experiments

Nice-to-have

  • Green Belt certification in Six Sigma
  • Strong mission and multicultural community values
  • Experience with neurovascular product transfers
  • Project management using MS Project software

Key Requirements

  • Master's degree in Mechanical or Biomedical Engineering
  • 4 years of experience in medical device process occupation
  • Experience with Class II or III implantable devices
  • Proficiency in SolidWorks and MiniTab software
  • Knowledge of fixture design and development

Work Rights

Not specified

Tailored Resume

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