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.
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.
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
