Lead Systems Engineer - Verification

GE HealthCare•Waukesha, WI

1d•Hybrid

About The Position

The Lead Systems Engineer will lead systems engineering and verification and validation activities for next-generation Infant Care Incubators and Warmers. The role translates clinical, customer, regulatory, and business needs into system requirements, architecture, and verification and validation strategies throughout the medical device development lifecycle. It involves partnering with Product Management, Clinical, Quality, Regulatory, Service, Hardware, Software, Program Management, Manufacturing, and Marketing teams to deliver safe, reliable, compliant, and manufacturable products. The position provides technical ownership for system-level integration, risk management, problem solving, design control, and product verification and validation. The engineer will support design transfer, regulatory readiness, commercial release, quality and compliance activities, and responses to field or customer issues, while maintaining a focus on clinician workflow, newborn safety, and scalable product platforms. The role is based with the development team in Waukesha, Wisconsin, with onsite work required at least three days per week.

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Systems Engineering, Computer Science, or a related STEM field.
At least 4 years of engineering experience in medical devices, healthcare technology, regulated product development, or a related field.
At least 3 years of experience supporting product development and design controls, including requirements management, risk management, verification, validation, and design reviews.
Experience translating customer, clinical, regulatory, and business needs into system requirements, architecture, interfaces, and verification strategies.
Experience planning and executing verification and validation activities, including test strategy and protocol development, test execution, requirements traceability, and demonstration of risk control effectiveness.
Working knowledge of complex electromechanical, software-enabled, or connected medical device systems and subsystem interactions.
Willingness to work onsite with the development team in Waukesha, Wisconsin, at least 3 days per week.
Legal authorization to work in the United States; employment visa sponsorship is not available.

Nice To Haves

Experience developing medical devices for neonatal or maternal-infant care, patient monitoring, respiratory care, life support, or other safety-critical clinical environments.
Strong systems engineering experience with electromechanical, software-enabled, or sensor-based products.
Familiarity with medical device standards including IEC 60601-1, IEC 60601-2-19, and IEC 60601-2-21.
Experience applying verification and validation principles to system-level testing, requirements traceability, risk control effectiveness, or design validation for regulated medical devices.
Ability to lead technical decisions, resolve ambiguity, manage tradeoffs, and communicate recommendations clearly across cross-functional teams.
Experience with reliability, serviceability, manufacturability, cybersecurity, connectivity, embedded systems, or other regulated product development considerations.
Familiarity with GE HealthCare quality systems, design control processes, or Infant Care product platforms.

Responsibilities

Focus on verification and validation preparation, coordination, and execution for new product introduction programs.
Lead systems engineering activities for next-generation Infant Care Incubators and Warmers, translating clinical, customer, regulatory, and business needs into system requirements and design inputs.
Drive design control execution, including requirements management, hazard analysis, risk management, integration planning, verification, validation, and design transfer.
Partner with cross-functional engineering, clinical, quality, regulatory, manufacturing, service, product management, and marketing teams to develop safe, reliable, compliant, and manufacturable solutions.
Lead system-level problem solving for neonatal care environments, considering performance, safety, serviceability, reliability, and compatibility across subsystems and accessories.
Develop and execute system integration, verification, and validation strategies to demonstrate product performance, risk control effectiveness, and readiness for regulatory submission and commercial release.
Identify, assess, and communicate technical risks, schedule impacts, and design tradeoffs; recommend mitigation plans that support program priorities and patient safety.
Provide technical design ownership by aligning cross-functional priorities, removing ambiguity, and maintaining engineering rigor.
Support quality, regulatory, and compliance activities, including design reviews, audits, corrective and preventive actions, and responses to field or customer issues.
Maintain focus on clinician workflow, newborn safety, rigorous verification and validation, and scalable platforms for multi-generational Infant Care product development.