Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required:

• 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

Preferred:

• 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

Skills & Competencies:

• 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

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
• Position requires being physically present on the premises during regular company hours or as approved by management

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