Sr. Controls Automation Engineer

Position Summary:

We are seeking a Controls Automation Engineer to support and enhance automated manufacturing systems within a high-volume medical device manufacturing environment. This role is responsible for designing, programming, troubleshooting, validating, and optimizing PLC-controlled assembly and packaging equipment while ensuring compliance with FDA, GMP, and internal quality standards. The engineer will lead automation projects, support new equipment implementation, and drive continuous improvement initiatives to improve equipment reliability and manufacturing efficiency.

Key Responsibilities:

• Design, develop, program, and troubleshoot PLC-based automation systems using Allen-Bradley GuardLogix, CompactLogix, and ControlLogix platforms.
• Develop and maintain HMI applications using FactoryTalk ME and SE.
• Integrate and support Cognex and Keyence machine vision systems for automated inspection.
• Diagnose and resolve issues involving servo motors, motion control systems, robotics, and automated assembly equipment.
• Lead equipment validation activities, including FAT, SAT, Installation Qualification (IQ), and functional testing.
• Develop and maintain electrical schematics, operating procedures, functional specifications, software backups, and equipment documentation.
• Drive manufacturing process improvements to increase Overall Equipment Effectiveness (OEE), reduce downtime, and improve product quality.
• Participate in equipment procurement, supplier selection, design reviews, and commissioning of new manufacturing equipment.
• Support DFMEA, PFMEA, machine risk assessments, and Critical-to-Quality (CTQ) initiatives to ensure safe and reliable manufacturing processes.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and external suppliers to deliver automation projects on time and within scope.

Required Qualifications:

• Bachelor's degree in Electrical Engineering, Controls Engineering, Electromechanical Engineering, Mechatronics, or a related discipline.
• 4 years of experience in controls, automation, or manufacturing engineering.
• Hands-on experience programming Allen-Bradley PLCs (GuardLogix, CompactLogix, or ControlLogix) and developing FactoryTalk HMI applications.
• Experience with Cognex or Keyence vision systems, robotics, and servo motion control.
• Ability to read and interpret electrical schematics and apply NFPA standards.
• Experience with equipment validation, including FAT, SAT, IQ, and commissioning.
• Strong troubleshooting, root cause analysis, and project management skills.

Preferred Qualifications:

• Experience in medical device or other FDA-regulated manufacturing environments.
• Knowledge of automated packaging systems, Form-Fill-Seal equipment, robotic assembly, and automated labeling systems.
• Familiarity with GMP, ISO 13485, validation documentation, and continuous improvement methodologies such as Lean Manufacturing and Six Sigma.