Staff Engineer, Manufacturing

Enable Injections Inc.•Sharonville, OH

5d•Onsite

About The Position

The Staff Engineer, Manufacturing designs, specifies, implements, and supports highly automated assembly and test equipment in a high-volume, regulated manufacturing environment. The role works with robotics, motion control, vision inspection, PLCs, HMIs, SCADA systems, and related automation and data connectivity. It leads equipment troubleshooting and continuous improvement, supports equipment and process validation, and maintains relevant quality-system documentation in compliance with applicable FDA and ISO standards. The position collaborates with cross-functional teams and automation suppliers to deliver projects on time and within budget, while improving equipment effectiveness, yield, efficiency, quality, and reliability. It also provides technical guidance and mentorship to engineers and technicians. The role is onsite and requires physical presence during regular company hours or as approved by management.

Requirements

Bachelor’s degree in Mechanical Engineering from an accredited university.
At least 8 years of manufacturing engineering experience in a regulated industry such as medical device or pharmaceutical.
At least 6 years of experience participating in validation and qualification activities for manufacturing equipment and processes.
Hands-on experience designing, integrating, and implementing highly automated assembly lines, including robotics, motion control, and inspection systems.
Experience collaborating with cross-functional project teams and automation suppliers.
Experience with high-volume manufacturing of 1 million or more units annually and cycle times under 10 seconds.
Strong hands-on experience with automation controls and programming, including Allen-Bradley PLCs, HMIs, SCADA systems, and data acquisition networks.
Experience with automated testing, vision inspection, and servo-driven motion platforms.
Deep understanding of SCARA, Cartesian, and collaborative robots, and industrial networking protocols including EtherNet/IP and OPC-UA.
Experience with ISO Class 8 cleanroom manufacturing and contamination control strategies.
Ability to optimize OEE, line efficiency, and equipment reliability using TPM and RCM methodologies.
Strong application of Lean manufacturing principles, including value stream mapping, SMED, and kaizen facilitation.
Proficiency in equipment design, validation, and lifecycle management, including IQ, OQ, and PQ.
Advanced skills in process optimization, data analysis, and problem solving.
Effective communication, technical writing, and presentation skills.
Strong supplier management and technical coaching skills.
Deep understanding of Lean Six Sigma, process capability analysis (Cp, Cpk, Ppk), and MSA.
Experience facilitating kaizen events, DOE studies, and SPC monitoring.
Understanding of MES, ERP systems, and automation data connectivity for traceability and performance tracking.
Adaptability and resilience in dynamic, high-volume manufacturing environments.
Advanced troubleshooting and optimization skills for PLC-, HMI-, and SCADA-based control systems supporting automated production equipment.
Skill in robot programming, motion control tuning, and vision system calibration for automated assembly and inspection equipment.
Must be able to remain stationary for extended periods and constantly operate a computer and other office equipment.
Ability to crouch, stoop, bend around and potentially underneath equipment for extended periods.
Must be physically present on the premises during regular company hours or as approved by management.

Nice To Haves

Six Sigma Black Belt (CSSBB) or Certified Manufacturing Engineer (CMfgE).
Proficiency with SolidWorks, Minitab, PLC programming software such as Studio 5000/RSLogix, and Microsoft Office Suite.
Experience with digital twin technologies or line simulation modeling for capacity and throughput analysis.
Knowledge of GAMP 5, ISO 13485, and Title 21 CFR Part 820 for equipment and software validation.
Robot programming or integration experience with major platforms such as FANUC, ABB, or Epson, and/or vendor automation certifications.

Responsibilities

Design, specify, and implement fully automated assembly and test equipment, including robotics, motion control, and vision inspection systems.
Program, configure, and troubleshoot PLCs, HMIs, SCADA systems, and robotic controllers supporting automated production lines.
Lead troubleshooting and continuous improvement efforts for automated equipment to enhance performance, quality, and reliability.
Execute and support process validation activities, including IQ, OQ, and PQ, and prepare documentation in compliance with FDA and ISO standards.
Develop and implement Standard Operating Procedures, training, and qualification documentation.
Support relationships with automation suppliers, participate in design reviews, and execute Factory Acceptance Tests and Site Acceptance Tests.
Drive improvements in OEE, yield, and efficiency using Lean Six Sigma tools.
Provide technical guidance and mentorship to engineers and technicians.
Develop and maintain Quality System documentation related to manufacturing processes and equipment.
Collaborate with cross-functional teams to deliver automation and manufacturing engineering project goals on time and within budget.
Support risk management through FMEA and other preventive quality tools.