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.