Automation Engineer in Orange County

Job Description

Required Qualifications

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• Bachelor’s degree in Mechanical, Manufacturing, Electrical, Mechatronics, or a related engineering discipline.

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• 7+ years of experience in automation, equipment engineering, or manufacturing engineering within medical device or other highly regulated manufacturing environments.

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• Demonstrated ownership of manufacturing equipment through installation, qualification, sustaining support, and change management.

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• Experience developing user requirements specifications (URS), technical requirements, and validation protocols.

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• Experience with automated or semi-automated assembly, testing, or inspection equipment.

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• Ability to interpret mechanical drawings, electrical schematics, and pneumatic diagrams.

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• Strong troubleshooting, technical writing, project management, and cross-functional communication skills.

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• Working knowledge of FDA regulations, Good Manufacturing Practices (GMP), ISO 13485, risk management, and change control.

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• Proficiency in SolidWorks.

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Qualifications

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• Familiarity with machine vision system setup, calibration, and basic programming for defect detection, part , and presence/absence verification.

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• Experience designing fixtures or mechanical equipment improvements using CAD software.

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• Experience with robotics, servo motion, pneumatic systems, sensors, or PLC/HMI-controlled equipment.

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• Familiarity with preventive maintenance program development, spare parts planning, calibration, and equipment lifecycle management.

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Salary Range: $115K - 145K base, plus bonus and stock options

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Located in Irvine, CA