Manufacturing Engineering Technician I (2nd Shift)

Job Description

Job Title: Manufacturing Engineering Technician I

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy. The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

At Terumo we believe in the power of personal growth and will encourage you to get in the drivers seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver whats next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.Join us and help shape wherever we go next!Advancing healthcare with heart

Job Summary

Provide direct support to engineering, process, planning performing a variety of key tasks related to the Mfg. process, Equipment, Maintenance, Calibration, and others.

Job Details/Responsibilities

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• Maintain production and quality by ensuring operation of machinery and mechanical equipment.
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• 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, manufacturers instructions, and engineering specifications.
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• Locate sources of problems by observing mechanical devices in operation, listening for problems, using precision measuring and testing instruments. Troubleshooting malfunctions
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• Determine changes in dimensional requirements of parts by inspecting used parts, using rules, calipers, micrometers, and other measuring instruments.
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• 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.
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• Maintain a safe and clean working environment by complying with procedures, rules, and regulations.
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• Maintain, schedule, and manage the calibration process for equipment.
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• Write and submit purchase requisitions for parts, components, calibration, etc.
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• Monitor and review non-conforming and rework data.
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• Provide production and engineering support.
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• Execute IQ/OQ/PQ and TMV
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• Complete assigned technical tasks
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• Perform testing.
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• Develop, test, and evaluate prototype processes.
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• Revise Manufacturing Instructions, Product Travelers, Tool Files
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• Carry out engineering builds, testing and data analysis.
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• Develop gauges and processing fixtures.
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• Develop new test fixtures and document methods.
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• Log evaluations into Engineering Notebook
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• Perform time studies and investigations.
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• Build racks, fixtures, lighting, wiring, etc.
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Job Responsibilities

Working Conditions/Physical Requirements.

COMPANY REQUIREMENTS

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

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

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

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

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