Automation & Controls Engineer

ptncmed; Irvine, Northern (CA, KY); Hybrid; USD 115,000 - 130,000; Full time

Benefits offered by this job

401(k) with employer contribution

Medical, dental, vision benefits

Paid holidays and vacation

Job summary

Precision Tube & Catheter, Inc. is seeking an Automation & Controls Engineer to maintain, troubleshoot, and improve manufacturing equipment for medical devices in Irvine, CA.

You will support automation, validation, and continuous improvement while ensuring regulatory compliance in a fast-paced environment. The role collaborates with production, quality, and engineering teams, leads CAPA, supports SCADA/MES data acquisition, and contributes to digital factory initiatives.

Qualifications

• Bachelor's degree in automation, electrical, mechatronics or related field.
• Minimum 5 years in manufacturing automation or controls engineering; medical device experience preferred.
• Strong knowledge of PLCs, HMIs, servo drives, VFDs, sensors, and industrial comms.

Responsibilities

• Maintain and troubleshoot production equipment across tubing and catheter lines.
• Lead RCA and CAPA for recurring failures.
• Support installation, FAT/SAT, IQ/OQ/PQ qualification of new equipment.
• Advance automation upgrades and OEE improvement initiatives.
• Contribute to SCADA/MES data acquisition and digital factory efforts.

Skills

Analytical skills

Problem solving

English fluency

Cross-functional teamwork

Communication

Chinese language

Education

Bachelor's degree in Automation/Electrical/Mechatronics

Tools

Siemens PLC

Omron PLC

Mitsubishi PLC

Allen-Bradley PLC

HMI development

Keyence vision

Cognex vision

Industrial robots

Job description

Job Description: Automation & Controls Engineer

Category: Manufacturing

Location: Irvine, CA 92618

Company Overview

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.

Position Summary

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.

Key Responsibilities

• 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.

Qualifications

• 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 cross-cultural teams.
• Proficiency in data analysis tools and statistical process control (SPC) is a plus.
• Must be legally authorized to work in the U.S. without employer sponsorship (no H-1B visa sponsorship available).

Key Performance Indicators

KPI

Target

Equipment Uptime (3 Extrusion / 5 PET Heat Shrink / 4 Braiding Lines)

> 98%

Preventive Maintenance (PM) Completion

> 95%

Mean Time to Repair (MTTR)

< 2 hrs

OEE Improvement

+5% year-over-year

Validation Support (IQ/OQ/PQ)

100%

Safety

Working Conditions

Work is performed in both an office and manufacturing environment, requiring adherence to safety protocols.

May involve standing for extended periods, occasional lifting of materials, and occasional travel for equipment installation as needed.

Base Salary: US$115,000–130,000, commensurate with experience.

Bonus: 5–10% target, based on individual and company performance.

We believe our employees are our greatest resource. We offer a competitive salary and benefits package including 401(k) with employer contribution, paid holidays, and vacation. Insurance coverage includes medical, dental, vision, and prescription drugs.

We are proud to be an equal-opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know. If applying for positions in the U.S., you must be eligible to work in the U.S. without needing an employer-sponsored visa (work permit).

Why Join PT&C

At PT&C, you will be part of a dedicated team that values innovation, integrity, and collaboration. As an Automation & Controls Engineer, you will play a critical role in keeping our production lines running reliably, driving continuous improvement, and contributing to the development of cutting-edge medical products that enhance patient care globally.

Precision Tube & Catheter, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.