Staff Controls Engineer

Enable Injections Inc.•Sharonville, OH

3d•Onsite

About The Position

This role focuses on designing, specifying, and implementing fully automated assembly and test equipment control systems. The Staff Controls Engineer will support the development of electrical, controls, and software architecture for new automation equipment, from concept and prototyping through fabrication, programming, and final validation testing. Responsibilities include programming, configuring, and troubleshooting PLCs, HMIs, SCADA systems, and robotic controllers. The engineer will lead troubleshooting and continuous improvement efforts for automated equipment controls to enhance performance, quality, and reliability. This position also involves supporting process, software, and computer system validation activities and documentation in compliance with FDA 21 CFR Part 820 and Part 11, and ISO standards. Additionally, the role includes developing and implementing Standard Operating Procedures, operator and technician training, and qualification documentation for automated equipment control systems. The engineer will lead capital automation equipment procurement, including supplier evaluation, design reviews, and Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs). A key aspect of the role is driving improvements in Overall Equipment Effectiveness (OEE), yield, and throughput on automated production equipment through controls enhancements. The Staff Controls Engineer will provide technical guidance and mentorship to engineers and technicians, develop and maintain Quality System documentation, and collaborate with cross-functional teams to deliver automation and controls engineering project goals. Support for risk management through FMEA and other preventive quality tools is also required.

Requirements

Bachelor’s degree in Electrical, Mechanical, Controls, Mechatronics, or related Engineering from an accredited university.
A minimum of 10 years of controls and automation engineering experience supporting automated manufacturing equipment in a regulated industry (medical device, pharmaceutical, or similar); or a master’s degree plus 6 years of experience.
Proven hands-on experience designing, programming, and integrating highly automated assembly and test equipment, including PLC-based control systems, HMI/SCADA architectures, robotics, and motion control.
Demonstrated experience collaborating with cross-functional project teams and automation suppliers.
Experience supporting automated production equipment in a high-volume manufacturing environment (1M+ units annually, cycle time less than 10 seconds).
Advanced proficiency programming and architecting Allen-Bradley PLC platforms (e.g., CompactLogix, ControlLogix) in ladder logic and/or structured text, HMI development (e.g., Ignition), SCADA systems, and industrial data collection/database architectures (e.g., MS SQL).
Experience with automated testing, vision inspection, and servo-driven motion platforms.
Deep understanding of robotic systems (SCARA, Cartesian, and collaborative robots) and industrial networking protocols (EtherNet/IP, OPC-UA).
Demonstrated ability to improve Overall Equipment Effectiveness (OEE) through controls and automation engineering, including PLC/HMI/SCADA-based downtime and fault data collection, alarm and diagnostic strategies, and cycle-time and motion optimization.
Proficient in controls system design and equipment lifecycle management.
Experienced in software and equipment validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Advanced skills in automated equipment performance optimization, controls and production data analysis, and structured root-cause problem solving.
Effective communicator with excellent technical writing and presentation skills.
Strong skills in supplier management and technical coaching.
Working knowledge of Lean Six Sigma, process capability analysis (Cp, Cpk, Ppk), and Measurement System Analysis (MSA) as applied to automated assembly, test, and inspection equipment.
Experience facilitating equipment-focused kaizen events, Design of Experiments (DOE) studies, and Statistical Process Control (SPC) monitoring using automated data collection from production equipment.
Deep understanding of Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, SQL-based data collection databases, and automation data connectivity for traceability and performance tracking.
Adaptability and resilience in dynamic, high-volume manufacturing environments.
Advanced troubleshooting and optimization of PLC, HMI, and SCADA-based control systems supporting automated production equipment.
Skilled in robot programming, motion control tuning, and vision system calibration for automated assembly and inspection equipment.
Ability to navigate ambiguity and influence technical decisions at the department and organizational level.
Familiarity with project management fundamentals and tools (e.g., Microsoft Project) to plan and execute capital equipment projects.

Nice To Haves

Proficiency with SolidWorks, Minitab, and Microsoft Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
Knowledge of Good Automated Manufacturing Practice (GAMP) 5, International Organization for Standardization (ISO) 13485, and Title 21 CFR Part 820 and Part 11 for equipment and software validation.
Experience with cleanroom manufacturing (International Organization for Standardization (ISO) Class 8) and contamination control strategies.
Vendor automation or robot certifications, or hands-on programming experience specific to FANUC, ABB, or Epson controllers.
Experience with capital automation equipment procurement and project management, including supplier evaluation and contract negotiation.
Six or more years of experience participating in equipment, software, and computer system validation and qualification activities (IQ, OQ, PQ) in compliance with FDA 21 CFR Part 820 and Part 11.

Responsibilities

Design, specify, and implement fully automated assembly and test equipment control systems, including PLC, HMI, SCADA, robotics, motion control, and vision inspection integration.
Support the development of electrical, controls, and software architecture for new automation equipment, from concept and prototyping through fabrication, programming, and final validation testing.
Program, configure, and troubleshoot PLCs (Allen-Bradley), HMIs (e.g., Ignition), SCADA systems, and robotic controllers supporting automated production lines.
Lead troubleshooting and continuous improvement efforts for automated equipment controls to enhance performance, quality, and reliability.
Support process, software, and computer system validation activities (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) and documentation in compliance with Food and Drug Administration (FDA) 21 CFR Part 820 and Part 11, and International Organization for Standardization (ISO) standards.
Develop and implement Standard Operating Procedures, operator and technician training, and qualification documentation for automated equipment control systems, including software configuration management and change control.
Lead capital automation equipment procurement, including supplier evaluation, design reviews, and Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).
Drive improvements in Overall Equipment Effectiveness (OEE), yield, and throughput on automated production equipment through controls enhancements — PLC and HMI code optimization, motion tuning, fault diagnostics, and equipment data analysis — supported by Lean Six Sigma tools.
Provide technical guidance and mentorship to engineers and technicians on controls and automation design practices.
Develop and maintain Quality System documentation related to automated manufacturing equipment, control systems, and automation software.
Collaborate with cross-functional teams (product development, manufacturing, quality, and regulatory) to deliver automation and controls engineering project goals on time and within budget.
Support risk management through Failure Mode and Effects Analysis (FMEA) and other preventive quality tools.