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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 environment 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.