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.

Mandate Skills:

1. System Engineering for medical devices (12+ years, 8+ years in medical device industry)
2. Requirements Engineering & Traceability Management
3. System Architecture & Solution Definition
4. Cross-Functional Design Integration (HW, SW, Mechanical, Clinical)
5. Risk Management & Systems Safety (ISO 14971)
6. Knowhow of medical device standards and regulations

Roles and Responsibilities:
- Lead the end-to-end system design of respiratory therapy devices, including hardware, firmware, and software integration.
- Define system-level requirements and specifications in collaboration with cross-functional teams.
- Evaluate the technical, regulatory,



and safety implications of engineering and design change requests to ensure system integrity and compliance throughout the product lifecycle.
- Identify and define Critical to Safety (CTS) and Critical to Quality (CTQ) parameters during design and development.
- Support verification and validation (V&V;) activities across system and subsystem levels.
- Maintain and update traceability matrices for system requirements, risks, and testing.
- Ensure adequate traceability from design inputs to verification outputs and risk mitigations.
- Apply solid understanding of safety risk management, including: DFMEA, Product risk analysis, Risk mitigations
- Ensure compliance with ISO 14971 and other relevant risk management standards.
- Demonstrated knowledge of global regulatory frameworks including: FDA 21 CFR Part 820.30, ISO 13485, IEC 60601 series, ISO 14971

📌 System Engineer medical devices (Pune)
🏢 Tata Elxsi
📍 Pune