Manufacturing Engineering Technician II

Terumo•Davie, FL

4d•Onsite

About The Position

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 driver's 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 what's 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 www.terumoaortic.com

Requirements

3+ years’ Maintenance Experience working in a production environment with mechanical, electrical, pneumatic, and PLC systems.
Experience with Calibration and Preventative Maintenance
3+ years manufacturing experience
2+ years of direct medical device experience
Understanding of quality system (e.g. 21CFR820, ISO13485) requirements.

Nice To Haves

Experience with Computer Aided Design (AutoCAD, SolidWorks)
Ability to read drawings and schematics
Experience with SAP or another ERP system

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