Respiratory Systems Architect

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:

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