Manufacturing Equipment Specialist

JOB DESCRIPTION

The Manufacturing Equipment Specialist serves as the plant-wide owner of manufacturing equipment reliability, lifecycle management, preventive maintenance, qualification, and continuous improvement. This role establishes and maintains the systems, documentation, and maintenance strategies necessary to ensure manufacturing equipment remains safe, compliant, reliable, and capable of supporting production objectives.

The Manufacturing Equipment Specialist is responsible for the complete lifecycle of manufacturing equipment—from specification and installation through qualification, maintenance, calibration coordination, upgrades, and retirement. This role partners closely with Production, Manufacturing Engineering, Quality, and Facilities to maximize equipment availability, support new product introductions, and drive continuous operational improvement.

This role complies with FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

• Manufacturing Equipment Ownership
• Serve as the technical owner for manufacturing equipment including:
• Assembly equipment
• Manufacturing fixtures
• Test equipment
• Packaging equipment
• Inspection equipment
• Automated manufacturing systems
• Production support equipment
• Equipment Lifecycle Management
• Develop equipment standards and specifications.
• Support equipment selection and procurement.
• Coordinate equipment installation and commissioning.
• Maintain equipment history and lifecycle documentation.
• Develop long-term equipment replacement strategies.
• Preventive Maintenance Program
• Develop, implement, and continuously improve the plant's preventive maintenance program.
• Schedule and coordinate preventive maintenance activities.
• Monitor maintenance effectiveness and equipment reliability.
• Identify opportunities for predictive and reliability-centered maintenance improvements.
• Equipment Qualification & Validation
• Support equipment qualification activities including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Equipment change assessments
• Equipment commissioning
• Validation documentation support
• Equipment Reliability & Performance
• Monitor equipment uptime and downtime trends.
• Lead root cause investigations related to equipment failures.
• Improve equipment reliability and overall equipment effectiveness (OEE).
• Recommend upgrades and modifications that improve equipment performance.
• Calibration Coordination
• Own the coordination of production equipment calibration activities.
• Maintain calibration schedules and records.
• Support audit readiness and regulatory compliance.
• Partner with Quality to ensure calibration requirements are maintained.
• Documentation & Compliance
• Maintain and control:
• Equipment specifications
• Preventive maintenance procedures
• Equipment operating procedures
• Maintenance records
• Spare parts documentation
• Equipment history files
• Continuous Improvement
• Standardize equipment maintenance practices across the plant.
• Improve equipment reliability, maintainability, and uptime.
• Support Lean Manufacturing and continuous improvement initiatives.
• Evaluate new technologies and equipment improvements.
• Cross-Functional Collaboration
• Partner closely with:
• Production
• Manufacturing Engineering
• Quality Engineering
• Facilities
• Supply Chain
• Validation
• Equipment suppliers and service providers
• SUPERVISOR RESPONSIBILITIES:

The position does not have supervisor responsibilities.

• Education
• Associate's or Bachelor's degree in Manufacturing Technology, Industrial Technology, Mechanical Technology, Electronics, Mechatronics, or related technical field preferred.
• Equivalent combination of education and experience will be considered.
• Experience
• 5+ years supporting manufacturing equipment in a regulated manufacturing environment.
• Experience with preventive maintenance systems and CMMS software.
• Experience supporting equipment qualification and validation.
• Experience troubleshooting mechanical, electrical, pneumatic, or automated manufacturing equipment.
• Medical device manufacturing experience preferred.
• COMPENTENCIES:
• Manufacturing equipment systems
• Preventive and predictive maintenance
• Equipment troubleshooting
• IQ/OQ and equipment qualification principles
• Calibration coordination
• Root cause analysis
• Equipment documentation and change control
• Lean Manufacturing and continuous improvement
• Strong analytical, organizational, and communication skills
• PHYSICAL DEMANDS AND WORK ENVIRONMENT:
• The work environment characteristics described…