System Engineer medical devices

Job description

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 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