Job Description SummaryThe Lead Systems Engineer will play a key role on the Infant Care team, leading systems engineering activities for next-generation Incubators and Warmers that help clinicians provide safe, reliable, and compassionate care for newborns. This role partners with Product Management, Clinical, Quality, Regulatory, Service, Hardware, Software, and Program Management teams to translate customer and clinical needs into system requirements, architecture, risk management, integration, verification, and validation strategies across the medical device development lifecycle. The Lead Systems Engineer will focus and drive verification and validation activities for Infant Care products. This position requires strong technical judgment, systems thinking, and a passion for solving complex healthcare challenges that improve outcomes for vulnerable patients and the caregivers who support them.
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Job DescriptionRoles and Responsibilities - Focus on V&V preparation, coordination and execution for NPI program(s).
- Lead systems engineering activities for next-generation Infant Care Incubators and Warmers, translating clinical, customer, regulatory, and business needs into clear 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 engineering, clinical, quality, regulatory, manufacturing, service, product management, and marketing teams to deliver safe, reliable, compliant, and manufacturable Infant Care solutions.
- Lead system-level problem solving for neonatal care environments, ensuring performance, safety, serviceability, reliability, and compatibility across subsystems and accessories.
- Develop and execute system integration, verification, and validation strategies that 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 practical mitigation plans that support program priorities and patient safety.
- Provide technical design ownership to cross-functional teams by aligning 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 that support multi-generational Infant Care product development.
Required Qualifications- 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, healthcare technology, regulated product development, or a related field.
- Minimum of 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 on site a minimum of 3 days per week with the development team in Waukesha, Wisconsin.
- Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Desired Characteristics- Experience developing medical devices for neonatal, 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 applicable 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 is a plus.
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We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
