Familiarity with IEC 60601 family of standards BS in Computer Science or related field What You Will Be Doing Tech Breakdown...
interfaces, such as I2C, SPI, UART, and GPIO Familiarity with medical device regulations and standards (e.g., ISO 13485, IEC...
, and external spend. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations...
of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971..., AAMI TIR57, IEC 60601 series, IEC 62366. Solid understanding of developmental best practices for medical device software...
, Software Testing, SDLC, IEC 62304, CMMI, Agile). Ability to organize and present technical and project mgt. overviews...
related safety engineering field Experience participating on relevant standard development committees (i.e. ISO, IEC...
1815-DNP3 and ICCP–IEC 60870-6/TASE.2 and advises on applicability of those standards across the organization. Thorough...
and associated protocols (Modbus, DNP3, IEC-61850) Experience with generator/multi-source paralleling controls Experience...
, and IEC 62304 Mentors and provides guidance to junior software engineers, sharing knowledge and best practices to support... compliance with regulatory standards such as FDA, ISO 13485, or IEC 62304 preferred. Strong understanding of real-time operating...
. Experience in communication protocols such as Modbus, OPC, DNP3, IEC 60870-5-104 Experience of contracting, engineering design...