NovintiX · Hyderabad
Looking for a Systems Engineer to support medical-device product development and act as a technical integrator across Mechanical, Electrical, Software, Quality, Regulatory, and Product Management teams. Key Responsibilities include capture and translate user needs and product requirements into system requirements, develop and maintain requirements specifications and traceability, define system architecture and subsystem interfaces, support HW/SW/mechanical integration and system-level testing, perform risk management, Hazard Analysis, and FMEA, support Design Controls, DHF, Verification & Validation (V&V), participate in design reviews and resolve system-level technical issues, and support regulatory documentation, design transfer, and product commercialization. Required Skills: Degree in Systems, Electrical, Mechanical, Biomedical Engineering, or related field, experience in medical-device/product development preferred, strong knowledge of Requirements Engineering, System Architecture, Risk Management, and V&V, experience with DOORS, Jama, Polarion, or similar tools, knowledge of ISO 14971, ISO 13485, FDA Design Controls, and IEC 60601, experience with FMEA, Design Controls, DHF, and technical documentation, and Cybersecurity/IEC 62304 exposure is an advantage.
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