Senior Manager, FLC
Core
Lead a multidisciplinary organization for Hardware & Systems Verification of electro-mechanical medical devices, spanning electrical, mechanical, and V&V engineering to drive end-to-end product realization from concept to commercialization.
Role type
Senior Manager, Hardware & Systems Verification
Builds
Safe, compliant, high-quality electro-mechanical medical devices for cardiology, patient monitoring, airway clearance, and ventilation
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Hardware design (electrical + mechanical), Embedded systems and controls integration, System-level verification and validation, Quality assurance, Organizational leadership, Talent pipeline management, Regulatory compliance (FDA, ISO, IEC), Risk management (FMEA, hazard analysis), Test automation, Six Sigma methodologies
Preferred skills
Digital engineering and digital twins, AI-driven validation approaches, Modular platform development, Advanced sensing and connectivity integration, Medical device product experience
Technologies
Mixed-signal electronics, Power electronics, Sensors, Control systems, Fluid management, Plastics, Simulation tools, Test lab infrastructure
Responsibilities
Define and execute strategy for Hardware and Systems Verification functions, Build and lead high-performing teams across Electrical, Mechanical, and V&V disciplines, Lead end-to-end product development lifecycle including architecture definition and transfer to manufacturing, Ensure compliance with safety, regulatory, and quality requirements, Drive automation of test systems and infrastructure, Partner with global cross-functional teams including Quality, Regulatory, and Manufacturing
Seniority
Senior, hands-on IC with strategic leadership