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