System architect (Medical devices)

Tata Elxsi; Pune District; Sur place; INR 3 500 000 - 6 000 000; Plein temps

Résumé du poste

Tata Elxsi, Inc. participates in medical device design and development, covering hardware and software integration, verification and regulatory compliance. The role emphasizes NPD/NPI and sustenance engineering with exposure to MTBF, risk management and MBSE practices.

Ideal candidates will have deep embedded knowledge, experience with RTOS, and familiarity with FDA, EU MDR, ISO 13485, IEC 60601-1, and related standards. Collaboration across teams is essential for successful product realization.

Qualifications

• Bachelor’s or Master’s degree in Electronics/ Electronics & Computer/ Mechatronics Engineering.
• 12+ years of relevant experience in medical devices.
• Minimum 5 years in NPD/NPI and sustenance engineering.

Connaissances

Embedded systems

ARM/Intel processors

Regulatory knowledge (FDA, EU MDR, ISO

MBSE (Cameo)

RTOS (VxWorks, Micrium uc/OS)

Firmware development

System modeling (SPICE, MATLAB)

Communication skills

Formation

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

Outils

Cameo MBSE

MATLAB

SPICE

EDA tools

Description du poste

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
• Effective verbal/written communication, documentation, presentation, and interpersonal skills, as well as the ability to work both independently and as part of a team
• 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.