Senior Systems Engineer

Job Description SummaryThe Senior Systems Engineer will play a key role on the Infant Care team, leading systems engineering activities for the development of next-generation Incubators and Warmers that help clinicians provide safe, reliable, and compassionate care for newborns. This role is responsible for collaborating with cross-functional teams (Product Management, Clinical, Quality, Regulator, Service, Hardware, Software, Program Management) to complete feature design by translating customer and clinical needs into system requirements, architecture, risk management, integration, verification, and validation strategies across the full medical device development lifecycle. The Senior Systems Engineer will also own and drive the Usability engineering process for Infant Care products. This position requires strong technical judgment, systems thinking, and a passion for solving complex healthcare challenges that improve outcomes for the most vulnerable patients and the caregivers who support them.
Here’s a link to learn about our products and what we’re building: https://www.gehealthcare.com/en-us/products/maternal-infant-care
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

• 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.
• Own system architecture, requirements flow down, interface definition, design tradeoffs, risk retirement, and traceability across hardware, software, mechanical, electrical, and clinical workflows.
• 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, usability, 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 leadership to systems engineers and cross-functional partners 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, caregiver usability, 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 6 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 supporting usability engineering or human factors activities, including workflow analysis, use-related risk, formative evaluation, summative validation, or usability-related design inputs.
• Working knowledge of complex electromechanical, software-enabled, or connected medical device systems and subsystem interactions.
• Willingness to work on site a minimum of 4 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, IEC 60601-2-21, and IEC 62366-1.

• Experience applying usability engineering or human factors principles to clinical workflows, use-related risk, formative studies, or summative validation.

• 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.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

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.