Staff Software Systems Engineer- Medical Device
Core
Technical leader guiding development of complex, software-driven medical device systems for the Neurosurgical group, ensuring alignment of stakeholder needs, system architecture, and regulatory compliance.
Role type
Staff Software Systems Engineer (Medical Device)
Builds
Software-driven medical device systems for neurosurgical applications
Domain
Medical Devices / Neurosurgery / Systems Engineering
Deliverable
production ML models | product features | infrastructure
Required skills
Systems engineering, Software development, Requirements management, System architecture, Integration, Verification, Validation, Traceability, Design controls compliance, Agile collaboration
Preferred skills
Complex software system optimization, Requirements management tools, System modeling, SDLC/ALM process influence, Effort estimation, Regulatory compliance knowledge, Static/dynamic code analysis
Technologies
Requirements management tools, System modeling tools, ALM tools
Responsibilities
Translate user and clinical needs into traceable high-level software requirements; Contribute to early concept development and system architecture decisions; Drive software system integration, verification, and validation; Establish and maintain end-to-end traceability across requirements and implementation; Coach teams on compliant requirement development; Partner with Agile teams to prioritize features; Collaborate with Quality, Regulatory, and R&D teams; Support Voice of Customer activities; Contribute to Design History File documentation.
Seniority
Staff, technical leadership & hands-on IC