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:

o DFMEA

o Product risk analysis

o Risk mitigations

Ensure compliance with ISO 14971 and other relevant risk management

standards.

Demonstrated knowledge of global regulatory frameworks including:

o FDA 21 CFR Part 820.30

o ISO 13485

o IEC 60601 series

o ISO 14971

Maintain documentation for Design History File (DHF), traceability matrices,

and risk files.

Experience with requirement management tools (e.g., IBM DOORS) and

lifecycle management platforms (e.g., Windchill).

Collaborate with mechanical, electrical, software, quality, and regulatory teams

throughout the product lifecycle. Lead and participate in design reviews, risk

assessments, and Phase Gate Reviews.