System Engineer Medical Devices

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 Elxsis 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 strong 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