MUST HAVE A BS IN BIOMEDICAL OR MECHANICAL ENGINEERING AND CO-OP OR INTERNSHIP EXPERIENCE WITH COMPONENT AND SYSTEMS TEST, TEST METHODS, AND INVESTIGATIONS.
The engineer participates in technical projects in support of combination products and medical devices including development, manufacturing and design changes. Product types vary and include plastic disposable and implantable products, electromechanical devices, and devices with integrated software.
The primary job duties include the physical testing and analysis of Medical Devices/Disposables, and Packaging throughout the various stages of the product design and manufacturing process.
Specific topics involved in your work are:
• Component and System Tests
• Test Methods
• Product Complaint Investigations
• Protocols and Final Reports
Responsibilities include, but are not limited to, the following:
• Conduct testing and analyses on Medical Devices, Containers, and Packaging components under minimum supervision.
• Uses analytical skills and/or conducts investigations of the design, operation and performance of the medical device component or system.
• Prepare or review drawings, engineering calculations, specification sheets and other documentation
• Operate laboratory instrumentation (, etc.) and computer systems to collect and record data.
• Manage inventory of laboratory supplies.
• Perform equipment maintenance and calibrations as required.
• Document testing in Electronic Data System (eLN). Maintain accurate and complete quality records.
• Maintain data integrity and ensure compliance with internal specifications,.
• Follow SOP’s and policies on cGMP’s and safety. Maintain a clean, safe and organized lab area, and assume responsibility to ensure that others maintain their lab areas.