Manufacturing Sr. Technician
Sunrise, FL, US
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.
Position Summary
The Manufacturing Engineering Technician ensures production equipment availability through Preventative Maintenance, repairs/troubleshooting, and calibration. Assists engineers with new process development activities, process evaluations, validation testing, test fixture development, and production/process troubleshooting.
Key Accountabilities:
- 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, 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.
Budget managed (if applicable) NA
Internal Networking/Key relationships:
This position requires cooperating with different company departments, such as R&D, Regulatory, Operations, Logistics, Finance, and the other team members of the department.
Minimum Skills and Capabilities:
- Work with all departments of the Company
- Able to work closely with assemblers
- Able to communicate with Engineers
- Ability to organize and conduct experiments
- Ability to analyze and solve technical problems
- Good oral and written communication skills (English)
- Hands-on experience building prototypes, tooling, and test fixtures
Minimum Knowledge & Experience required for the position:
- 5+ 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, Solid works), 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.
- Machining experience (Mill, Lathe, Drill Press), preferred
- 5+ years manufacturing experience
- 2+ years of direct medical device experience
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.