Principal Engineer, Manufacturing

Enable Injections Inc.•Sharonville, OH

47d•Onsite

About The Position

Lead manufacturing equipment specification, design, development, and implementation of fully automated assembly and test equipment Lead troubleshooting and continuous improvement efforts to enhance equipment performance, quality, and reliability Lead process validation activities (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) and documentation in compliance with Food and Drug Administration (FDA) and International Organization for Standardization (ISO) standards Develop and implement Standard Operating Procedures, training, and qualification documentation Manage relationships with automation suppliers, lead design reviews, and oversee Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) Drive improvements in Overall Equipment Effectiveness (OEE), yield, and efficiency using Lean Six Sigma tools Provide technical guidance, mentorship, and leadership for engineers and technicians Develop and maintain Quality System documentation related to manufacturing processes and equipment Lead cross-functional teams to deliver strategic manufacturing goals on time and within budget Support risk management through Failure Mode and Effects Analysis (FMEA) and other preventive quality tools

Requirements

Bachelor’s degree in Mechanical Engineering from an accredited university
A minimum of 12 years of manufacturing engineering experience in a regulated industry (medical device, pharmaceutical, or similar)
A minimum of 10 years of experience leading/participating in validation and qualification activities for manufacturing equipment and processes
Proven leadership in design and implementation of highly automated assembly lines, including integration of robotics, motion control, and inspection systems
Demonstrated experience leading cross-functional project teams and supplier collaborations
Experience with high-volume manufacturing (1M+ units annually, less than 1-second cycle time)
Strong understanding of automation controls and programming, including Allen-Bradley Programmable Logic Controllers (PLCs), Human Machine Interfaces (HMIs), Supervisory Control and Data Acquisition (SCADA) systems, and data acquisition networks
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)
Experience with cleanroom manufacturing (International Organization for Standardization (ISO) Class 8) and contamination control strategies
Demonstrated ability to optimize Overall Equipment Effectiveness (OEE), line efficiency, and equipment reliability using Total Productive Maintenance (TPM) and Reliability-Centered Maintenance (RCM) methodologies
Strong application of Lean manufacturing principles, including value stream mapping, Single-Minute Exchange of Die (SMED), and kaizen leadership
Expert in equipment design, validation, and lifecycle management, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Advanced skills in process optimization, data analysis, and problem solving
Effective communicator with excellent technical writing and presentation skills
Strong leadership in supplier management and technical coaching
Deep understanding of Lean Six Sigma, process capability analysis (Cp, Cpk, Ppk), and Measurement System Analysis (MSA)
Experience leading kaizen events, Design of Experiments (DOE) studies, and Statistical Process Control (SPC) monitoring
Understanding of Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, and automation data connectivity for traceability and performance tracking
Adaptability and resilience in dynamic, high-volume manufacturing environments
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
Position requires being 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, and Microsoft Office Suite
Experience with digital twin technologies or line simulation modeling for capacity and throughput analysis
Knowledge of Good Automated Manufacturing Practice (GAMP) 5, International Organization for Standardization (ISO) 13485, and Title 21 CFR Part 820 for equipment and software validation

Responsibilities

Lead manufacturing equipment specification, design, development, and implementation of fully automated assembly and test equipment
Lead troubleshooting and continuous improvement efforts to enhance equipment performance, quality, and reliability
Lead process validation activities (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) and documentation in compliance with Food and Drug Administration (FDA) and International Organization for Standardization (ISO) standards
Develop and implement Standard Operating Procedures, training, and qualification documentation
Manage relationships with automation suppliers, lead design reviews, and oversee Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs)
Drive improvements in Overall Equipment Effectiveness (OEE), yield, and efficiency using Lean Six Sigma tools
Provide technical guidance, mentorship, and leadership for engineers and technicians
Develop and maintain Quality System documentation related to manufacturing processes and equipment
Lead cross-functional teams to deliver strategic manufacturing goals on time and within budget
Support risk management through Failure Mode and Effects Analysis (FMEA) and other preventive quality tools