System Engineer

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: