Lead Systems Engineer - Verification
GE HealthCare · gehealthcare.com
WaukeshaLead / Manager4+ yrs
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The job in short
A lead / manager Systems / Network Administrator role at GE HealthCare in Waukesha, asking for 4+ years of experience. Skills mentioned: Marketing, Product management, Clinical, Compliance.
MarketingProduct managementClinicalCompliance
Details
- Found
- 5 d ago · posted 2026-11-04
- Location
- Waukesha, Wisconsin, États-Unis d'Amérique
Full description
Job Description Summary
L'ingénierie des systèmes est une discipline d'ingénierie interfonctionnelle axée sur une approche, un état d'esprit et un processus. Toutes les activités qui tiennent compte des besoins à la fois commerciaux et techniques des clients dans le but de fournir un produit de qualité qui réponde aux besoins des utilisateurs. Discipline qui exécute un processus robuste de conception, de création et d’optimisation de systèmes, comprenant l’identification et la quantification des exigences système, la création de concepts de conception de système alternatifs, la réalisation d’études commerciales de conception, la sélection et la mise en œuvre des meilleures conceptions et la vérification que la conception est correctement intégrée et exécutée. Processus allant du concept à l'exploitation en passant par la production.
Responsable de la planification et/ou de l'exécution des opérations du département ou axé sur l'exécution d'activités professionnelles au sein d'une discipline technique. Fonctions dotées d'une certaine autonomie, mais guidées par les politiques établies ou l'analyse des résultats finaux.
Ce poste est autorisé à modifier les procédures et les pratiques en relation avec les tâches dans la mesure où les résultats finaux répondent aux normes d'acceptabilité (qualité, volume, respect des délais, etc.).
Job Description
Roles 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 Information
GE 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).
Nonobstant le fait que GE HealthCare ne requiert actuellement pas des salariés américains (USA) qu'ils soient vaccinés contre la COVID-19, certains clients de GE HealthCare appliquent des règles de vaccination qui pourraient toucher certains salariés de GE HealthCare.
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