System Architect - Medical Devices

Overview

Tata Elxsi partners with top medical device manufacturers and technology firms, offering expertise in market analysis, human factors engineering, hardware and software development, verification, validation, and compliance with regulatory standards. Their medical device and healthcare division holds ISO 13485 certification and integrates cutting-edge technologies such as AI, cloud computing, and IoT.

Qualifications and Experience

Candidates should have a Bachelor's or Master's degree in Electronics, Electronics & Computer Engineering, or Mechatronics Engineering. A minimum of 12 years of relevant industry experience is required, including at least 5 years specifically in medical device development. Experience must encompass new product development (NPD), new product introduction (NPI), and maintenance engineering.

Essential Skills

• Comprehensive knowledge of both hardware and software aspects for integrated medical products.
• Hands-on experience with embedded microprocessors and microcontrollers like ARM and Intel processors.
• Familiarity with middleware software stacks such as Bluetooth, Wi-Fi, USB, and File Systems tailored for embedded platforms.
• Comfortable working across multiple operating systems, including Windows and Linux.
• Thorough understanding of international quality and regulatory standards for medical devices such as FDA, EU MDR, MDD, IEC 60601-1-1 (CE marking), ISO 13485, and IEC 62304.
• Expertise in safety risk management procedures, including Failure Mode and Effects Analysis (FMEA), design mitigation strategies, and compliance with risk management standards.
• Knowledge of Model Based Systems Engineering (MBSE) methodologies and tools, including experience with Cameo for model development.
• Strong customer engagement abilities.
• Excellent communication skills—verbal and written—along with capabilities in documentation, presentations, and teamwork.

Preferred Qualifications

• Experience with firmware development on real-time operating systems such as VxWorks or Micrium uc/OS.
• Ability in system-level circuit modeling using tools like EDA, SPICE, and MATLAB.
• Familiarity with design of experiment (DOE) methods.
• Knowledge of design for excellence principles including Design for Manufacturability (DFM), Design for Test (DFT), and Design for Reliability (DFR).
• Understanding of usability standards for medical devices following human factors engineering guidelines such as HFE/HE75, IEC 62366, and IEC 60601-1-6.