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Download K. Fowler (CRC, 2008) BBS - Web server administration
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Developing Real-Time Embedded Products 336 Systems engineer or architect Electronic hardware engineers Software and firmware engineers Information technology (IT) specialists (which may be a corporate function) Industrial designers Mechanical engineers Manufacturing engineers Technicians Documentation specialists Regulatory specialists and regulatory affairs representative Quality assurance (QA) Additional important groups: Clinical Packaging Purchasing Each of these people will probably overlap in function and expertise. Some people, particularly in smaller organizations, may wear several ‘‘hats’’ and do several different jobs simultaneously. The team lead manages the business of the team and assures that the project moves forward. They primarily care for the business case and for getting the appropriate people and expertise on staff for the project. The biomedical engineers will most likely have the greatest interaction with the clinicians, physicians, medical staffs, and marketing team. They usually are responsible for the project requirements and assure that testing addresses the metrics. They tend to have more interaction with the clinical staff than anyone else. The systems architect or engineer may be the team leader in small projects. In larger projects, the systems architect can play more of an advisory or mentoring role to the design team. A systems architect helps everyone see the ‘‘big picture’’ during development and can ease the functional integration of the different specialties. The electronic hardware engineers and technicians shepherd the development of the circuitry of the medical device. The team may need a range of expertise—digital, microprocessor, analog, and radio frequency (RF). They handle component selection, circuit board design and fabrication, and event tree analysis (ETA), fault tree analysis (FTA), and failure modes and effects analysis (FMEA); they prepare testing and record the results; they write instructions for assembly and prepare the bill of materials. In some cases, a team might even design the integrated circuit chip for a processor or application-specific integrated circuit (ASIC) for the medical device.
