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Mechanical Engineer Technologist’s play a vital role in the medical device field. Mechanical engineers in a test laboratory may hold the title of Testing and Reliability Engineer. Test engineers have a four-year bachelor’s degree in either Mechanical Engineering or Biomedical Engineering. “Mechanical Engineers can expect an average annual salary in the state of Indiana between $73,320-$82,780. According to the U.S. Bureau of Labor Statistics-May 2018.”
Some test engineers work in testing labs for medical device companies and help test minimally invasive devices. Medical devices are tested for strength, durability, and efficiency. Test engineers must have a thorough understanding of the mechanics of medical devices. They must also have a thorough understanding of human anatomy to understand how the devices will be used inside the body. They help create drawing designs for products, tools, and fixtures. Tools and fixtures are used to build and test medical devices. Test engineers sometimes reverse engineer tools, fixtures, and equipment. The ability to reverse engineer these tools, fixtures and, equipment is cost-efficient for the company. Some test engineers use CADD software technology to create drawings, which can then be used in the design, production, and testing of medical devices. Drawing can also be used by the (QCI) to inspect the product for tolerance conformity.
Medical devices are built to standard. Most companies build their product to ISO standards. ISO is the International Organization for Standardization. It is based out of Geneva, Switzerland. This organization sets standards for business operations all around the world. It is made up of 164 National Standard Bodies, one representative from each member country. An International Standard is- specifications used to build a quality product. Testing laboratories are regulated under ISO-IEC-17025-testing-and-calibration-laboratories.
Test Engineers/Directors have many responsibilities including; reviewing and approving test requests, ensuring test articles are received, recorded, and are appropriate for the test that is to be performed. They direct tests and are responsible for ensuring that testing is performed by the appropriate standardized test method. I.e. ISO: 10555-1: 2013 (en) They write protocols with instructions to be followed. The test engineer, director is responsible for making sure the right equipment is available and has been calibrated and recorded. They are responsible for making sure the test operator is trained to the test method, and they have a clear understanding of how the test is to be performed. The test operator will perform the test and record data. After testing is completed the test engineer will then analyze the data and write a report with the conclusions from the test. All ancillary data relating to the test is uploaded to PLM.
Agile-Product-Lifecycle-Management by Oracle is a tracking tool used by medical device companies as a data storage house to track the lifecycle of a medical device. It is used to track changes, provides a history of the beginning of a device in its research and development stages to its completion, implementation, and retirement. Medical companies upload documents such as drawings, specifications, manufacturing instructions, and test results such as raw data and reports. Test Engineers store their test results in PLM. They use PLM to pull up data from previous studies to use as a comparison for current testing.
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