Senior Staff Systems Designer
Core
Lead end-to-end systems engineering for digital cardiovascular ultrasound products, ensuring alignment of customer workflows, product functionality, quality, reliability, and regulatory compliance throughout the development lifecycle.
Role type
Senior Staff Systems Engineer (Medical Devices)
Builds
Digital cardiovascular ultrasound products and clinical applications
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models
Required skills
Systems engineering, requirements management, system architecture, risk management (FMEA), verification and validation, regulatory compliance, cross-functional leadership, design trade-off analysis, manufacturing support
Preferred skills
FMEA expertise, reliability engineering, new product introduction leadership, FDA/MDR/IEC standards knowledge, global stakeholder management
Technologies
AWS, Kubernetes, CI/CD, Infrastructure as Code, DICOM, HL7, FHIR
Responsibilities
Lead end-to-end systems engineering activities from concept to commercialization; Own definition and delivery of product features and clinical applications; Drive technical risk identification and ensure regulatory compliance; Lead cross-functional development teams; Ensure requirements flow-down and traceability; Conduct system design trade-off analyses; Lead design control activities including FMEA and CAPA; Serve as primary systems engineering representative for audits and regulatory submissions; Provide technical leadership and mentoring to engineering teams; Collaborate with global stakeholders to resolve complex technical challenges; Support manufacturing and customer issue resolution
Seniority
Senior Staff, hands-on IC with strategic influence
