Senior Systems Engineer
Core
Lead end-to-end systems engineering for cardiology medical devices from concept through commercialization, ensuring regulatory compliance and product quality.
Role type
Senior Systems Engineer (Medical Devices)
Builds
Cardiology product features and clinical applications
Domain
Healthcare technology / Medical devices
Deliverable
production ML models | product features | infrastructure
Required skills
Systems engineering lifecycle management, requirements definition and traceability, system architecture and design, risk management (FMEA, hazard analysis), verification and validation planning, cross-functional team leadership, regulatory compliance knowledge, design trade-off analysis, manufacturing support, root cause analysis
Preferred skills
Cardiology or healthcare product development experience, FMEA and reliability engineering expertise, FDA/MDR/IEC 60601/62304/ISO 14971 standards knowledge, new product introduction leadership, global stakeholder management
Technologies
Medical device development tools, regulatory submission platforms, FMEA software, V&V testing frameworks
Responsibilities
Define and deliver product requirements and architecture, lead cross-functional development teams, conduct risk identification and mitigation, manage design control activities, serve as primary representative for audits and regulatory submissions, mentor engineering teams, resolve complex technical challenges, support manufacturing and field service
Seniority
Senior, hands-on IC with strategic influence