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...