System architect (Medical devices)

Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT.Tata Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified.QualificationBachelor’s or Master’s degree in Electronics/ Electronics & Computer/ Mechatronics EngineeringExpected Experience12+ years of relevant experience with Minimum 5 years of in medical deviceExperience is NPD/NPI and sustenance engineering is a mustRequired SkillsIn-depth understanding of both hardware and software for integrated productsExperience with embedded microprocessors and microcontrollers such as ARM or Intel based processorsKnowledge of middleware software stacks such as Bluetooth, Wi-Fi, USB, File System for embedded platformComfort with heterogeneous environments (Windows, Linux)Knowledge of global quality and regulatory environment for medical devices including FDA, EU MDR, MDD, IEC 60601-1-1 (CE marking), ISO 13485, IEC 62304Strong understanding of safety risk management, including FMEA, design mitigations, and risk management standardsKnowledge of Model Based Systems Engineering (MBSE), tools, techniques, and concepts; e.g., Cameo model developmentStrong customer facing skillsEffective verbal/written communication, documentation, presentation, and interpersonal skills, as well as the ability to work both independently and as part of a teamDesirable SkillsFirmware experience with RTOS such as VxWorks, Micrium uc/OSSystem level circuit modelling with EDA tools, SPICE, MATLABDesign of experiment (DOE) methodologiesDesign for excellence viz. DFM, DFT, DFRUsability aspects of medical devices according to HFE/HE75, IEC 62366, IEC 60601-1-6 etc.