Sr. Staff Systems Engineer
Core
Lead the development and evolution of complex electro-mechanical medical devices, shaping system architecture and ensuring design control compliance.
Role type
Sr. Staff Systems Engineer (Medical Devices)
Builds
Complex electro-mechanical medical devices, diagnostics, and lab automation systems
Domain
Medical Technology / Healthcare
Deliverable
production ML models | product features
Required skills
Systems architecture, requirements management, system integration, verification and validation (V&V), risk management (dFMEA, hazard analysis), design control compliance (FDA/QSR, ISO 13485, IEC 6060-1), cross-functional leadership, project planning, cost analysis, test method development
Preferred skills
Navigating ambiguity in agile environments, influencing without formal authority, leading technical complexity, self-motivated learning
Technologies
Modern Requirements, PTC, Polarion, JAMA, DOORS
Responsibilities
Lead systems level design and development; define and maintain system architectures; translate stakeholder needs into actionable requirements; lead design reviews and approve V&V protocols; execute system-level testing and guide test method development; lead cross-functional risk management activities; mentor and coach engineers; develop project plans and control technical budgets
Seniority
Sr. Staff, hands-on IC with mentorship responsibilities
