Software Engineer Development or Testing
Core
Lead development of requirements flow down, architecture/system design, risk analysis, cybersecurity analysis, integration and test, and manufacturing support for ultrasound products to ensure regulatory compliance and commercialization.
Role type
Senior IC systems engineer (medical device)
Builds
Ultrasound products
Domain
Medical device / Ultrasound / Regulatory compliance
Deliverable
production ML models | product features | infrastructure
Required skills
Architecture and system design, risk analysis, cybersecurity analysis, integration and test, defect resolution, QMS compliance management, regulatory standards knowledge (IEC60601, ISO13485, FDA, MDR), cross-functional collaboration
Preferred skills
Mechanical engineering background, system or hardware background, supply chain and supplier management experience, hands-on installation, upgrade, and repair experience
Technologies
IEC60601, ISO13485, FDA, MDR
Responsibilities
Lead development of requirements flow down, manage technical program risks and design tradeoffs, ensure QMS compliance and DHF readiness, drive architecture decisions, manage defect resolution activities for design changes
Seniority
Senior, hands-on IC