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.

Qualification
Bachelor’s or Master’s degree in Electronics/ Electronics & Computer/ Mechatronics Engineering

Expected Experience
12+ years of relevant experience with Minimum 5 years of in medical device
Experience is NPD/NPI and sustenance engineering is a must

Required Skills
In-depth understanding of both hardware and software for integrated products
Experience with embedded microprocessors and microcontrollers such as ARM or Intel based processors
Knowledge of middleware software stacks such as Bluetooth, Wi-Fi, USB, File System for embedded platform
Comfort with heterogeneous environments (Windows, Linux)




Knowledge of global quality and regulatory setting for medical devices including FDA, EU MDR, MDD, IEC 60601-1-1 (CE marking), ISO 13485, IEC 62304
Strong understanding of safety risk management, including FMEA, design mitigations, and risk management standards
Knowledge of Model Based Systems Engineering (MBSE), tools, techniques, and concepts; e.g., Cameo model development
Strong customer facing skills
Effective verbal/written communication, documentation, presentation, and interpersonal skills, as well as the ability to work both independently and as part of a team

Desirable Skills
Firmware experience with RTOS such as VxWorks, Micrium uc/OS
System level circuit modelling with EDA tools, SPICE, MATLAB
Design of experiment (DOE) methodologies
Design for excellence viz. DFM, DFT, DFR
Usability aspects of medical devices according to HFE/HE75, IEC 62366, IEC 60601-1-6 etc.

📌 System architect (India)
🏢 Tata Elxsi
📍 India