Lead Systems Engineer, Neonatal Medical Devices

MS0100 Datex-Ohmeda, Inc.

Waukesha (WI)

In loco

USD 110.000 - 150.000

Tempo pieno

4 giorni fa

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Descrizione del lavoro

GE HealthCare is seeking a Lead Systems Engineer to guide the Infant Care team on incubators and warmers, translating clinical and regulatory needs into robust system requirements and design inputs. You will drive verification and validation activities, design controls, and risk management across the medical device lifecycle, collaborating with Product Management, Quality, Regulatory, and Manufacturing.

The role emphasizes strong systems thinking, cross-functional leadership, and a focus on

Competenze

Bachelor's degree in Engineering, Biomedical Engineering, Systems Engineering, Computer Science, or a related STEM field.
Minimum of 4 years of engineering experience in medical device or regulated product development.
Experience translating clinical and regulatory needs into system requirements and design inputs.
Experience with verification/validation activities, requirements traceability, and design reviews.

Mansioni

Focus on V&V preparation, coordination and execution for NPI programs.
Lead systems engineering activities for next-generation Infant Care incubators and warmers.
Drive design control execution, including requirements management, hazard analysis, risk management, verification, validation, and design transfer.
Partner with cross-functional teams to deliver safe, reliable, compliant, and manufacturable Infant Care solutions.
Lead system-level problem solving for neonatal care environments and ensure performance, safety, and reliability across subsystems.