Senior System Engineer
Core
Define system architecture, manage software lifecycle compliance, and perform risk/safety analysis for medical device software.
Role type
Senior System Engineer (Medical Device/Embedded Software)
Builds
Regulated medical device software systems and embedded solutions
Domain
Medical Technology / Embedded Systems / Regulatory Compliance
Deliverable
production ML models | product features | infrastructure
Required skills
System architecture design, Requirement traceability (SYS->SRS), Risk analysis (ISO 14971), Safety classification (IEC 62304), Verification strategy definition, Integration testing, Technical documentation, Agile/V-model processes
Preferred skills
SaMD experience, Embedded medical device knowledge, Quality management standards (ISO 13485)
Technologies
IEC 62304, ISO 14971, ISO 13485, IEC 62366, IEC 81001-5-1
Responsibilities
Define system architecture and allocate requirements to software components, Perform system-level risk analysis and define software safety classification, Support software development in compliance with IEC 62304, Define system and software verification strategies, Work with hardware, software, quality, and regulatory teams, Maintain technical documentation (architecture, interface specs)
Seniority
Senior, hands-on IC