System Engineer - Medical Devices

About Tata Elxsi Medical Device Practice

Tata Elxsi collaborates with prominent medical device original equipment manufacturers (OEMs) and technology firms, specializing in market research, human factors engineering, hardware and software development, verification and validation, and compliance with regulatory standards. Their Medical Device and Healthcare division is certified under ISO 13485, highlighting commitment to quality standards.

Key Responsibilities

• Oversee the comprehensive system design of respiratory therapy devices integrating hardware, firmware, and software components.
• Collaborate with interdisciplinary teams to establish system-level requirements and specifications.
• Assess design and engineering change requests for technical soundness, regulatory compliance, and safety implications to maintain system integrity throughout the product's lifecycle.
• Identify and specify Critical to Safety (CTS) and Critical to Quality (CTQ) parameters during product design and development phases.
• Contribute to verification and validation efforts at both system and subsystem levels.
• Maintain and regularly update traceability matrices linking requirements, risks, and testing procedures.
• Ensure complete traceability from design inputs through verification outputs and risk mitigation activities.
• Apply expertise in safety risk management techniques such as Design Failure Mode and Effects Analysis (DFMEA), product risk analyses, and risk mitigation strategies.
• Guarantee adherence to ISO 14971 and related risk management standards.
• Possess in-depth knowledge of global regulatory frameworks including FDA 21 CFR Part 820.30, ISO 13485, IEC 60601 series, and ISO 14971.

Required Skills and Experience

• At least 12 years of system engineering experience, including minimum 8 years within the medical device sector.
• Expertise in requirements engineering and traceability management.
• Proficiency in system architecture and solution definition.
• Experience with cross-disciplinary design integration involving hardware, software, mechanical, and clinical domains.
• Comprehensive understanding of risk management systems and standards pertinent to medical devices, notably ISO 14971.