Job Description:
The Primary Contact is an early graduate of the HST Program (Harvard / MIT) and currenting working as a Visiting Scientist in IMES – MIT Department of Mechanical Engineering. We are developing an FDA Class II Medical Device for the early identification and management of Generalized Atherosclerosis. This involves updating a Platform known as the Care365 Cardiac Platform. The Platform is composed of Hardware, Firmware, and Software. The Firmware is Embedded, and the Software includes a Graphic User Interface (GUI). The Hardware is fully designed and functional as a package. The Hardware Components are mounted on a Pneumo-Electric Board and include: 15 Valves, Air Pump, Linear Actuator / Piston, 2 Flow Meters, High-Resolution Pressure Transducer, NIBP (noninvasive blood pressure unit), Manifold, and associated wiring (harness) and tubing. The Software is also functional and ready for testing. The Software is written in C Sharp in the .net format. Firmware, in this application is essentially the Coding required to manage the selected Microcontroller. The board we are currently using is the Teensy 4.0. Teensy 4.0 features an ARM Cortex-M7 processor at 600 MHz, with a NXP iMXRT1062 chip. Further, the Firmware involves Microcontroller Embedded Development that serves as the major interface between Hardware and the GUI. The Firmware Components / Connectors are assembled on a SHIM Board, which resides on the Pneumo-Electric Board. This Job will focus on Finalization of Firmware and Firmware Testing. To assist in this tasking we have developed Patient Simulations with supportive Bench Electronics [Digital Storage Oscilloscope – SIGLENT SDS1104X-E and Strip Chart Recorder – Thornton Type:464] and Computers. Two Clinical Facilities are available where human volunteer subjects can be evaluated under an FDA Investigative Device Exemption (IDE). We are looking for applicants that can provide Firmware Innovation and can maintain careful testing records. Expert directional and analysis support will be provided.