Manufacturing Engineer II
$80,000–$100,000 year
On-site · Aliso Viejo, California, United States
Job Summary
Manufacturing Engineer II to lead sustaining efforts for Light Adjustable Lens and insertion-device manufacturing; drive continuous improvement, support Lean manufacturing, and ensure regulatory compliance (ISO 13485, FDA). Collaborates with Design Engineering and Quality Control/Assurance to maintain production-line sustainability, improve safety, quality, on-time delivery, and productivity; perform validation (IQ/OQ/PQ), develop drawings/work instructions, train staff, set up/maintain equipment, diagnose complex issues, participate in root-cause analysis and implement corrective actions.
Required Qualifications
- Bachelor’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 3 years of technical experience.
- Master’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 2 years of technical experience.
- Continuous improvement experience.
- Familiarity with regulatory standards (ISO 13485).
- Familiarity with GMP and GDP. Experience with GLP is a plus.
- CAD (SolidWorks or PRO/E proficiency)
- SolidWorks PDM software (desired)
- Experience in a cleanroom environment/medical device manufacturing preferred.
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