Required Qualifications
- Bachelor’s degree in Mechanical, Manufacturing, Electrical, Mechatronics, or a related engineering discipline.
- 7+ years of experience in automation, equipment engineering, or manufacturing engineering within medical device or other highly regulated manufacturing environments.
- Demonstrated ownership of manufacturing equipment through installation, qualification, sustaining support, and change management.
- Experience developing user requirements specifications (URS), technical requirements, and validation protocols.
- Experience with automated or semi-automated assembly, testing, or inspection equipment.
- Ability to interpret mechanical drawings, electrical schematics, and pneumatic diagrams.
- Strong troubleshooting, technical writing, project management, and cross-functional communication skills.
- Working knowledge of FDA regulations, Good Manufacturing Practices (GMP), ISO 13485, risk management, and change control.
- Proficiency in SolidWorks.
Ensure all your application information is up to date and in order before applying for this opportunity.
Preferred Qualifications
- Familiarity with machine vision system setup, calibration, and basic programming for defect detection, part orientation, and presence/absence verification.
- Experience designing fixtures or mechanical equipment improvements using CAD software.
- Experience with robotics, servo motion, pneumatic systems, sensors, or PLC/HMI-controlled equipment. xhqgsiq
- Familiarity with preventive maintenance program development, spare parts planning, calibration, and equipment lifecycle management.
Salary Range: $115K - 145K base, plus bonus and stock options
Located in Irvine, CA
Automation Engineer in orange at Unknown Company
This position is listed as full time and onsite.