Senior Manufacturing Automation Engineer

Cypress HCM; Irvine (CA); On-site; USD 115,000 - 145,000; Full time

Job summary

Cypress HCM in Irvine, CA seeks a manufacturing/automation engineer with 7+ years in regulated environments to own equipment from installation through qualification and sustaining support. You will drive change control, lifecycle maintenance, and cross‑functional collaboration to assure compliant processes.

Responsibilities include creating URS and technical requirements, supporting validation protocols, and working with automated or semi-automated assembly, testing, or inspection equipment.

Qualifications

• Bachelor’s degree in mechanical, manufacturing, electrical, mechatronics or related engineering field.
• 7+ years in automation, equipment or manufacturing engineering in regulated environments.
• Ownership of manufacturing equipment through installation, qualifications, sustaining support and change control.
• Experience with URS, technical requirements and validation protocols.
• Experience with automated or semi-automated assembly, testing or inspection equipment.
• Ability to read mechanical drawings, electrical schematics and pneumatic diagrams.
• Strong troubleshooting, technical writing, project management and cross-functional communication skills.
• Working knowledge of FDA, GMP, ISO 13485, risk management and change control.

Responsibilities

• Own manufacturing equipment through installation, qualification and sustaining support.
• Lead change controls and maintain equipment lifecycle documentation.
• Collaborate cross-functionally to ensure device compliance and process validation.
• Develop URS and technical requirements and support validation activities.

Education

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

Tools

SolidWorks

Job description

• 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