Job Description

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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