System Engineer

18 hours ago


Mumbai, India NMD Placement Consultancy Full time

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 - Maintain documentation for Design History File (DHF), traceability matrices, and risk files. - Experience with requirement management tools (e.g., IBM DOORS) and lifecycle management platforms (e.g., Windchill). - Collaborate with mechanical, electrical, software, quality, and regulatory teams throughout the product lifecycle.Lead and participate in design reviews, risk assessments, and Phase Gate Reviews. - Lead and participate in design reviews, risk assessments, and Phase Gate Reviews. Education & Skills preferred: - Degree preferred, MTech / BE/ BTECH in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or related field. - 3-10 years of experience in medical device product development, and overall 5-10 years of experience. - Experience with ventilators, CPAP, BiPAP, or similar life-support systems is highly preferred. - Basic understanding of system engineering principles and lifecycle. - Exposure to design controls and regulatory frameworks (e.g., FDA, ISO 13485). - Familiarity with risk management processes (e.g., ISO 14971). - Hands-on experience with testing, debugging, and documentation. - Knowledge of DOORS and Windchill would be added advantage. - Strong analytical and problem-solving skills. - job location : pune - SUBHADEEP - 9830203229



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