Sr. Manager, Systems Engineering, Point-Of-Care
San DiegoLast seen today
Summary
Senior Manager leading systems engineering for complex Point-of-Care diagnostic instruments, overseeing hardware, software, consumable, and assay integration. Responsible for system architecture, cross-functional integration with external partners, regulatory compliance (ISO 13485, IEC 62366, IEC 60601, ISO 14971), and risk analysis. Will mentor junior engineers, drive technical decision-making across R&D, Quality, Manufacturing, and Regulatory teams, and manage the full product lifecycle from concept through commercial launch in a regulated environment.
DevOps / InfrastructureTechnical Program ManagementContract ManufacturingCross Functional LeadershipElectrical EngineeringFluidicsHardware Software IntegrationIec 60601Iec 62366In Vitro Diagnostics IvdIso 13485Iso 14971MbseMechanical EngineeringMedical Device DevelopmentRegulatory ComplianceRequirements ManagementRisk AnalysisSystems ArchitectureSystems EngineeringVerification And Validation