System Engineer medical devices

Tata Elxsi, Inc.; Pune District; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Tata Elxsi seeks a senior System Engineer for medical devices to lead end-to-end system design of respiratory therapy devices, coordinating hardware, firmware, and software integration. You will define system-level requirements with cross-functional teams and assess regulatory, technical, and safety implications of changes to ensure product integrity throughout the lifecycle.

The role requires deep knowledge of ISO 14971 risk management, CTS/CTQ parameter identification, and strong traceability

Qualifications

• Extensive experience in system engineering for medical devices.
• Proven experience in requirements engineering and traceability management.
• Experience with cross-functional design integration (HW, SW, mechanical, clinical).
• Strong knowledge of ISO 14971 and regulatory frameworks.
• Familiarity with global regulatory standards (FDA 21 CFR Part 820.30, ISO 13485, IEC 60601 series).

Responsibilities

• Lead end-to-end system design of respiratory therapy devices, including hardware, firmware, and software integration.
• Define system-level requirements and specifications with cross-functional teams.
• Evaluate technical, regulatory, and safety implications of design changes to ensure integrity and compliance.
• Identify CTS and CTQ parameters during design and development.
• Support verification and validation activities across system and subsystem levels.
• Maintain and update traceability matrices for system requirements, risks, and testing.
• Ensure traceability from design inputs to verification outputs and risk mitigations.
• Apply safety risk management practices including DFMEA and risk analyses.
• Ensure compliance with ISO 14971 and other risk management standards.
• Demonstrate knowledge of FDA/ISO regulatory frameworks.

Skills

System engineering

Requirements engineering & traceabilty

Cross-functional design integration

Risk management & safety (ISO 14971)

Regulatory standards knowledge

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:

• System Engineering for medical devices (12+ years, 8+ years in medical device industry)
• Requirements Engineering & Traceability Management
• 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