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, i...