Automation & Controls Engineer

Job Description:

Automation & Controls Engineer

Category:
Manufacturing

Location:

Irvine, CA 92618

Precision Tube & Catheter, Inc. (PT&C) is a high-tech enterprise dedicated to manufacturing advanced materials and components for interventional and implantable medical devices, including extrusion tubing, PET heat shrink tubing, braided tubing, and catheter components. Our commitment to quality and innovation drives us to produce high-quality medical tubing and components that meet stringent industry standards and support healthcare professionals in delivering exceptional patient care.

The Automation & Controls Engineer is responsible for maintaining, troubleshooting, improving, and commissioning the manufacturing equipment used in medical device production while maximizing equipment uptime and supporting automation, validation, and continuous improvement initiatives. This position works closely with production, quality, and engineering teams to ensure equipment reliability, process consistency, and regulatory compliance in a fast-paced medical device manufacturing environment.

• Maintain and troubleshoot equipment across tubing and catheter manufacturing lines, including extrusion lines, heat shrink tubing expanders, braiders, and associated laser measurement systems, pullers, winders, compressors, chillers, nitrogen generators, vacuum systems, and utilities.
• Troubleshoot PLCs, HMIs, servo drives, VFDs, sensors, and electrical control systems to minimize downtime and maximize equipment uptime.
• Develop and maintain preventive maintenance (PM) programs and spare parts inventory for all production equipment.
• Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for recurring equipment failures.
• Support equipment installation, FAT/SAT, and IQ/OQ/PQ qualification for new and upgraded equipment.
• Support process optimization for extrusion, PET heat shrink tubing, braiding, and catheter manufacturing processes, partnering with process and mechanical engineers.
• Lead or participate in automation upgrade projects, new technology introduction, and OEE (Overall Equipment Effectiveness) improvement initiatives.
• Support digital factory initiatives, including SCADA/MES data acquisition, IoT deployment, and production data connectivity.
• Prepare and maintain technical documentation, including SOPs, electrical schematics, BOMs, validation reports, and maintenance records.
• Provide technical training and support to production operators and maintenance technicians on automation systems and best practices.
• Support compliance with ISO 13485, FDA 21 CFR Part 820, LOTO procedures, calibration programs, and change control processes.
• Work with equipment suppliers on acceptance testing, technical assessments, and continuous improvement of automation systems.
• Ensure compliance with safety protocols and contribute to maintaining a safe working environment.

• Bachelor's degree in Automation Engineering, Electrical Engineering, Mechatronics, or a related field.
• Minimum of 5 years of experience in manufacturing automation, industrial equipment maintenance, or controls engineering; experience in medical device manufacturing and plastic extrusion strongly preferred.
• Strong understanding of industrial control systems, including PLC programming (Siemens, Omron, Mitsubishi, or Allen-Bradley), HMI development, servo drives, VFDs, and industrial communication protocols.
• Hands-on troubleshooting experience with production equipment such as extruders, heat shrink tubing lines, braiding machines, pullers, winders, compressors, chillers, and vacuum systems.
• Experience with vision systems (Keyence, Cognex, Halcon) and robotics (Fanuc, ABB, KUKA, UR, Doosan) is a plus.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, IQ/OQ/PQ validation, LOTO, and calibration requirements.
• Excellent analytical and problem-solving skills, with the ability to lead root cause analysis and drive data-driven corrective actions.
• Effective communication skills, both verbal and written, in English (fluent) and Chinese (preferred), with the ability to collaborate across cross-functional and…