Summary

Required: 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.

Job description

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 (IQ, OQ, PQ) and documentation in compliance with FDA 21 CFR Part 820 and Part 11, and 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.

Qualifications

Required: 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.

Preferred: Proficiency with SolidWorks, Minitab, and Microsoft Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook). Knowledge of Good Automated Manufacturing Practice (GAMP) 5, ISO 13485, and Title 21 CFR Part 820 and Part 11 for equipment and software validation. Experience with cleanroom manufacturing (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.

Skills & Competencies: Proficient in controls system design and equipment lifecycle management. Experienced in software and equipment validation, including IQ, OQ, and 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.

Physical Requirements: Must be able to remain in a stationary position for extended periods of time. Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time. Must be able to access and navigate all areas of the facility, including cleanrooms. Position requires being physically present on the premises during regular company hours or as approved by management.

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.
Proficiency with SolidWorks, Minitab, and Microsoft Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
Knowledge of Good Automated Manufacturing Practice (GAMP) 5, ISO 13485, and Title 21 CFR Part 820 and Part 11 for equipment and software validation.
Experience with cleanroom manufacturing (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.
Proficient in controls system design and equipment lifecycle management.
Experienced in software and equipment validation, including IQ, OQ, and 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.

Company overview

Enable Injections Inc. is a Cincinnati-based healthcare innovation company specializing in the development and manufacturing of advanced wearable drug delivery systems. Founded in 2010 by medical device industry veteran Michael Hooven, the company has pioneered the enFuse® on-body delivery system, a revolutionary technology designed for subcutaneous administration of large-volume, high-viscosity biologic therapeutics. The enFuse system enables patients to self-administer medications that previously required clinic visits for intravenous infusions, offering greater convenience, improved patient experience, and potential healthcare cost savings. Enable Injections operates through strategic partnerships with pharmaceutical companies, designing customized injectors for specific drug applications while allowing partners to use their existing drug containers. The company has secured over $344 million in funding from notable investors including Sanofi, Magnetar Capital, and ORI Healthcare Fund, and has achieved regulatory approvals in multiple global markets including the United States, Brazil, and the United Kingdom. With its innovative approach to drug delivery, Enable Injections is positioned at the forefront of transforming patient care for chronic conditions requiring biologic therapies.