Software System Engineer
Core
Translating stakeholder and regulatory needs into testable software requirements and ensuring their elaboration into system design, integration, and verification within regulated environments.
Role type
Senior IC software system engineer (regulated/medical)
Builds
Medical software systems compliant with IEC 62304
Domain
Healthcare technology / Medical device software
Deliverable
production ML models | product features
Required skills
Requirements engineering, System design, Software design, System integration, Root cause analysis, Risk management, Verification planning, Agile development, IEC 62304 compliance, Technical issue investigation
Preferred skills
Harness Engineering, AI-assisted engineering workflows, Cybersecurity awareness, Product lifecycle management
Technologies
Harness Engineering, AI-assisted coding tools
Responsibilities
Translate stakeholder needs into clear, testable, and traceable software requirements; Collaborate with architects to define system architecture and integration strategies; Coordinate system decomposition and allocation of requirements to subsystems; Support development in regulated environments ensuring alignment with IEC 62304 and design controls; Drive investigation of technical issues and complaints through root cause analysis and corrective actions; Review system and software design proposals to identify conflicts and recommend improvements; Contribute to verification planning and integration readiness by defining conditions for successful validation.
Seniority
Senior, hands-on IC