System engineer (Regulatory & Medical devices)

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.
• 3-5 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.
• Good written and verbal communication skills.