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 Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified.
Mandate Skills:
System Engineering for medical devices (12+ years, 8+ years in medical device industry)
Requirements Engineering & Traceability Management
System Architecture & Solution Definition
Cross-Functional Design Integration (HW, SW, Mechanical, Clinical)
Risk Management & Systems Safety (ISO 14971)
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

Work arrangement
No