Manufacturing Engineering Technician II

Job Summary

The Manufacturing Engineering Technician II ensures production equipment availability through Preventative Maintenance, repairs/troubleshooting, and calibration. Assist engineers with new process development activities, process evaluations, validation testing, test fixture development, and production/process troubleshooting.

Job Details/Responsibilities

• Maintain production and quality by ensuring operation of machinery and mechanical equipment
• Ensure operation of machinery and mechanical equipment by completing preventive maintenance requirements on motors, pneumatic tools, ovens, and production machines by following diagrams, sketches, operations manuals, manufacturer's instructions and engineering specifications. 
• Locate sources of problems by observing mechanical devices in operation, listening for problems, using precision measuring and testing instruments. 
• Troubleshoot equipment and perform repairs and upgrades.
• Determine changes in dimensional requirements of parts by inspecting used parts; using rules, calipers, micrometers, and other measuring instruments
• Maintain equipment, parts, and supplies inventories by checking stock to determine inventory level, anticipating needed equipment, parts, and supplies and placing and expediting orders. Verify receipts.
• Maintain a safe and clean working environment by complying with procedures, rules, and regulations
• Maintain, schedule, and manage the calibration process for equipment
• Write and submit purchase requisitions for parts, components, calibration, etc. 
• Monitor and review non-conforming and rework data
• Provide production and engineering support 
• Execute IQ/OQ/PQ and TMV
• Update EMRs, MOPs, TMs, and other production documents
• Create and process change plans
• Complete assigned technical tasks
• Perform testing
• Develop, test, and evaluate prototype processes
• Revise Manufacturing Instructions, Product Travelers/DHRs, Tool Files
• Carry out engineering builds, testing and data analysis
• Develop gauges and processing fixtures
• Develop new test fixtures and document methods
• Log evaluations into Engineering Notebook
• Perform time studies and investigations
• Build racks, fixtures, lighting, wiring, etc

Job Responsibilities (continued)

Working Conditions/Physical Requirements

COMPANY REQUIREMENTS    

• Must work within requirements of company handbook and policy statements.
  Note: Company Handbook, Policy Statement and Authorisation of Limits do not form part of the quality system

QUALITY REQUIREMENTS   

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

•  Take care of your own health and safety and that of others who maybe affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• Basic understanding and application of engineering principles skills to assigned tasks.
• Developing command of Good Documentation Practices (GDP), technical report writing
• Ability to effectively communicate technical work performed.
• Developing understanding of engineering responsibilities to internal/external customers being supported
• Transition into workplace and Terumo culture; learning products and processes, and organizational role; developing and applying fundamental engineering skills.
• Drives improvement, innovation, and changes
• Completes work as assigned under close supervision on productivity and technical results.
• Teamwork to achieve a common goal.

Qualifications/ Background Experiences

• 3+ years’ Maintenance Experience working in a production environment with mechanical, electrical, pneumatic, and PLC systems.
• Experience with Calibration and Preventative Maintenance
• Experience with Computer Aided Design (AutoCAD, SolidWorks), preferred.
• Ability to read drawings and schematics, preferred.
• Experience with SAP or another ERP system, preferred.
• Understanding of quality system (e.g. 21CFR820, ISO13485) requirements.
• 3+ years manufacturing experience
• 2+ years of direct medical device experience