Automation & Controls Engineer, Medical Devices

Precision Tube & Catheter, Inc.; Irvine (CA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

401(k) with employer contribution

Paid holidays and vacation

Medical, dental, vision insurance

Job summary

Precision Tube & Catheter, Inc. is hiring an Automation & Controls Engineer to maintain and upgrade manufacturing equipment for medical devices. You will troubleshoot PLCs, HMIs, servo drives, and sensors while driving preventive maintenance programs and CAPA actions.

You will support installation, qualification, and validation activities (IQ/OQ/PQ), optimize extrusion and braiding processes, and contribute to digital factory initiatives and safety compliance in a fast-paced facility.

Qualifications

• Bachelor's degree in Automation Engineering, Electrical Engineering, Mechatronics, or related field.
• 5+ years in manufacturing automation or controls engineering; medical device manufacturing preferred.
• Strong understanding of industrial control systems including PLC programming, HMI development, servo drives, VFDs, and industrial communication.
• Hands-on troubleshooting with extrusion lines, braiding, heat shrink tubing, and related equipment.
• Experience with vision systems and robotics is a plus.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820; IQ/OQ/PQ validation is a plus.
• Fluent English; Chinese preferred; ability to collaborate across cross-functional teams.
• Must be legally authorized to work in the U.S. without visa sponsorship.

Responsibilities

• Maintain and troubleshoot manufacturing equipment across tubing and catheter lines.
• Troubleshoot PLCs, HMIs, servo drives, and sensors to minimize downtime.
• Develop and maintain PM programs and spare parts inventory.
• Lead RCA and implement CAPA for equipment failures.
• Support installation, FAT/SAT, and IQ/OQ/PQ validation for new equipment.
• Support process optimization and automation upgrade projects.
• Lead or participate in OEE improvement initiatives.
• Support SCADA/MES data acquisition and IoT deployment.
• Prepare technical docs: SOPs, schematics, BOMs, validation reports.
• Provide training to operators and maintenance teams.

Skills

PLC programming

HMI development

Servo drives

VFDs

Industrial networks

Troubleshooting

Data analysis / SPC

Safety compliance

Education

Bachelor's degree in Automation/Electrical/Mechatronics

Tools

Siemens PLC

Omron PLC

Mitsubishi PLC

Allen-Bradley PLC

HMI tools

Keyence/Cognex Halcon vision

Job description

Precision Tube & Catheter, Inc. is hiring an Automation & Controls Engineer to maintain and upgrade manufacturing equipment for medical devices. You will troubleshoot PLCs, HMIs, servo drives, and sensors while driving preventive maintenance programs and CAPA actions.

You will support installation, qualification, and validation activities (IQ/OQ/PQ), optimize extrusion and braiding processes, and contribute to digital factory initiatives and safety compliance in a fast-paced facility.