Lead Systems Engineer - Verification
Core
Lead systems engineering and verification/validation activities for next-generation Infant Care Incubators and Warmers to ensure safe, reliable, and compliant medical devices for newborns.
Role type
Lead Systems Engineer (Verification & Validation)
Builds
Next-generation Infant Care Incubators and Warmers
Domain
Medical Devices / Neonatal Care / Regulated Product Development
Required skills
Systems Engineering, Verification & Validation, Requirements Management, Risk Management, Design Control, Hazard Analysis, Test Strategy Development, Regulatory Compliance, Cross-functional Leadership, Technical Problem Solving
Preferred skills
Neonatal/Maternal Infant Care experience, Electromechanical systems expertise, IEC 60601 standards familiarity, Reliability engineering, Embedded systems knowledge
Technologies
IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21
Responsibilities
Lead V&V preparation, coordination, and execution for NPI programs; Translate clinical and regulatory needs into system requirements and design inputs; Drive design control execution including requirements management and risk analysis; Partner with cross-functional teams to deliver compliant solutions; Lead system-level problem solving for neonatal care environments; Develop and execute integration and validation strategies for regulatory submission; Identify and mitigate technical risks; Support quality audits and corrective actions.
Seniority
Senior, hands-on IC