Staff Controls Engineer, Manufacturing

Enable Injections

Cincinnati, OH

Pay: $125,000+/yr

Shift: Full time

**Location:** Onsite

**Status Type:** Full Time

**Company**

Founded in 2010, Enable Injections is a healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse.

enFuse is a wearable drug delivery solution featuring the first-ever purely mechanical hands-free wearable technology designed to deliver large volumes of pharmaceutical and biologic therapeutics subcutaneously, in which patients receive their needed treatment through a simple injection under the skin, instead of intravenously.

**Position**

The primary purpose of this position is to provide advanced Systems Level (automation, electrical, and controls engineering) technical expertise for the design, development, integration, and continuous improvement of highly automated manufacturing equipment used in the production of medical devices, in compliance with domestic and international regulatory requirements. This position applies deep controls and automation engineering knowledge to support product commercialization, scalability, and reliability. The Staff Controls Engineer collaborates closely with other engineers, designers, manufacturing, quality, and regulatory staff, and mentors other engineers, to ensure specifications are met with technically strong, high-quality, cost-effective designs following a defined development process.

**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, 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.

**Skills & Competencies:**

• 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 Pla