Lead Engineer - Systems Engineering
Core
Lead end-to-end systems engineering for New Product Introduction (NPI) and productivity programs, ensuring feature integrity, design intent, and regulatory compliance across hardware and software modules.
Role type
Lead Systems Engineer
Builds
High-quality medical device products and system architectures
Domain
Healthcare / Medical Devices / Systems Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems engineering lifecycle management, requirements development and traceability, system design and analysis, FMEA, risk management, verification and validation, hardware/software integration, configuration control, CTQ/Risk trade-off analysis, technical design review leadership, regulatory compliance translation
Preferred skills
Lean/Design for Six Sigma (DFSS), Design for Reliability (DFR), complex problem solving in fast-paced environments, cross-functional collaboration
Technologies
N/A
Responsibilities
Own end-to-end systems deliverables including requirements, design, analysis, FMEA, risk management, and V&V; Lead system-level activities and serve as the main integrator between hardware and software functions; Design and deliver system architecture and conduct component/product integration; Define product requirements for module/component teams; Drive Critical to Quality (CTQ) and risk trades; Manage product configuration and control systems; Lead technical design reviews and test strategy definition
Seniority
Senior, hands-on IC with leadership responsibilities