remote
Senior Systems Engineer - GE HealthCare
Systems Engineer
Lead systems engineering for next‑generation infant care incubators and warmers, translating clinical needs into robust system requirements, architecture, and validation strategies while ensuring regulatory compliance and cross‑functional collaboration.
About the role
Key Responsibilities
- Translate customer and clinical requirements into detailed system specifications and architecture for infant care devices.
- Lead risk management, verification, and validation activities across hardware and software components.
- Collaborate with Product Management, Clinical, Quality, Regulatory, Service, Hardware, Software, and Program Management teams to ensure seamless integration and compliance.
- Develop and maintain system-level documentation, including design reviews, risk assessments, and validation plans.
- Drive continuous improvement of engineering processes and tools to enhance product quality and time‑to‑market.
Requirements
- 10+ years of systems engineering experience in medical device development.
- Deep knowledge of risk management (ISO 14971), V&V (IEC 62304), and regulatory pathways (FDA, CE).
- Proficiency in hardware/software integration, architecture design, and cross‑functional collaboration.
- Strong communication skills and ability to lead multidisciplinary teams.
- Experience with infant care or similar life‑support medical devices is highly desirable.
Skills
software developmentsystem designproblem solving