8-12+ years of relevant experience in design & development (End to end class-3 Medical device esp. preferred) of system/sub-system. Expertise in Analog design, Digital design, Power supplies, and Microcontrollers. Design and document the development for manufacturability (i.e., drawings, schematics , experiments, changes, test results, data, PCB layout , etc.) Generate failure modes and effects analysis, complete engineering drawings as per guidelines, manufacturing instructions, and technical input to the operator\xe2\x80\x99s manual. Experience in Reliability engineering fundamentals \xe2\x80\x93life data analysis (Weibull, etc.); system reliability modelling; reliability growth analysis; accelerated testing (HALT/HASS), MTBF, Design for Reliability (DfR) Should have performed hands-on EMC, Environment, and Electrical safety tests. Ability to independently create BoM aligned with Schematics, work on costing with online/Offline vendors, ROHS/REACH components verification, and Lifecycle management of critical components.
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