Controls Engineer - Medical Devices

Flex•Austin, TX

2d•Onsite

About The Position

The Controls Engineer is responsible for the design, implementation, maintenance, troubleshooting, and continuous improvement of automated manufacturing equipment used in the production of medical devices. This role supports production uptime, equipment reliability, product quality, and regulatory compliance through the application of industrial automation technologies, including Allen-Bradley PLCs, FactoryTalk HMIs, OSI PI SCADA systems, and Cognex vision systems. The Controls Engineer works closely with Controls Technicians, Maintenance, Manufacturing Engineering, Quality, Validation, and Production teams to resolve equipment issues, execute automation improvement projects, and ensure manufacturing systems operate safely and efficiently.

Requirements

Bachelor's degree in Electrical Engineering, Controls Engineering, Computer Engineering, or related technical discipline preferred, will consider controls related experience.
3+ years of experience supporting automated manufacturing equipment.
Experience with Allen-Bradley PLC platforms including: ControlLogix CompactLogix Studio 5000
Experience with FactoryTalk View ME/SE HMI development.
Experience with industrial Ethernet networks and communication protocols.
Experience troubleshooting automation systems in a manufacturing environment.
Strong understanding of electrical control systems, sensors, actuators, VFDs, and motion control systems.

Nice To Haves

Experience in medical device, pharmaceutical, biotechnology, or regulated manufacturing environments.
Experience with OSI PI System or similar SCADA/data historian platforms.
Experience with Cognex In-Sight or VisionPro vision systems.
Familiarity with FDA regulations, GMP requirements, and validation processes.
Experience with MES, SQL databases, data analytics, or Industry 4.0 initiatives.
Knowledge of machine safety standards and risk assessment methodologies.

Responsibilities

Provide technical support for automated manufacturing equipment to maximize machine uptime and production efficiency.
Troubleshoot and resolve issues involving Allen-Bradley PLCs, FactoryTalk HMIs, industrial networks, motion control systems, and field devices.
Investigate recurring equipment faults and implement corrective actions to improve reliability.
Support production during equipment failures, startup activities, and process disruptions.
Assist in root cause analysis and develop sustainable solutions to prevent recurring issues.
Develop, modify, test, and maintain PLC programs using Rockwell Studio 5000 and related software platforms.
Design and improve FactoryTalk View SE/ME HMI applications to enhance operator usability and equipment diagnostics.
Create and maintain PLC documentation, tag databases, alarm definitions, and system architecture drawings.
Implement automation standards and best practices across manufacturing equipment.
Lead and execute PLC and HMI improvement projects to enhance safety, reliability, throughput, and maintainability.
Develop machine performance enhancements including: Improved fault diagnostics and alarm handling, Cycle time reductions, Automated data collection, Enhanced operator interfaces, OEE improvement initiatives, Predictive maintenance capabilities.
Identify opportunities to modernize legacy controls systems and improve production efficiency.
Support and maintain OSI PI data collection and visualization systems.
Develop and manage equipment performance dashboards, production metrics, alarm monitoring, and operational reporting tools.
Ensure accurate collection and storage of manufacturing data for quality, traceability, and operational analysis.
Collaborate with Manufacturing Engineering and Operations teams to leverage process data for continuous improvement initiatives.
Configure, troubleshoot, and optimize Cognex vision inspection systems used for product verification, quality assurance, and process control.
Develop and maintain vision inspection programs and communication interfaces with PLCs and manufacturing equipment.
Support validation and implementation of new vision inspection applications.
Work closely with Controls Technicians to diagnose and resolve production equipment issues.
Provide technical guidance and mentorship to Controls Technicians during troubleshooting and repair activities.
Develop troubleshooting procedures, standard work, and training materials.
Participate in shift support initiatives and escalation processes for critical manufacturing equipment.
Review machine downtime events and partner with technicians to identify long-term corrective actions.
Support equipment qualification, validation, and change control activities in accordance with medical device manufacturing requirements.
Ensure automation systems comply with applicable regulatory standards, quality systems, and company procedures.
Participate in risk assessments, FATs, SATs, IQ/OQ/PQ activities, and audit support.
Maintain detailed technical documentation including: PLC and HMI backups, Electrical drawings, Network architecture diagrams, Functional specifications, Change control records.
Manage automation projects from concept through deployment and production support.
Coordinate with vendors, integrators, and internal stakeholders on automation-related initiatives.