TATA Elxsi
Website:
tataelxsi.com
Job details:
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
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