Lead System Designer at GE HealthCare in Shanghai, Shanghai, China

Lead System Designer
Location: Shanghai
Job Description Summary
This role leads systems engineering for ultrasound digital products, defining requirements, architecture, and interfaces across hardware, software, and cloud. The candidate drives system design from concept to commercialization while ensuring compliance with medical device standards and regulations. Requirements include a Master's degree in Systems Engineering or a related field, 5+ years of systems engineering experience, and strong knowledge of medical device lifecycles and design controls. Desired experience includes diagnostic imaging, cloud-connected medical devices, AI/ML integration, and distributed healthcare architectures.

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 & Responsibilities
Lead systems engineering for ultrasound digital products, defining system requirements, architecture, interfaces, and end-to-end workflows across hardware, software, cloud, and connectivity.
Drive system design from concept to commercialization, aligning technical solutions with customer needs, clinical workflows, regulatory requirements, and business objectives.
Manage requirements traceability; translate user, stakeholder, regulatory, and product requirements into verifiable system-level requirements.
Lead system architecture and design trade-off analysis considering performance, usability, cybersecurity, safety, reliability, scalability, serviceability, cost, and regulatory compliance.
Collaborate closely with cross-functional teams including software, hardware, cloud, cybersecurity, quality, regulatory, clinical, manufacturing, and product management.
Ensure system designs comply with applicable medical device standards and regulations, including ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601 Series, IEC 81001-5-1, FDA, MDR, and other global regulatory requirements.
Drive design and technical reviews across all development phases, ensuring readiness for phase gates and regulatory submissions.
Partner with V&V teams to establish comprehensive V&V strategies, ensuring testable designs and full requirements traceability to objective evidence.
Develop and maintain system engineering deliverables within the DHF, including system specifications, architecture documents, interface definitions, risk files, and other design control documentation.
Support regulatory submissions, inspections, and audits as the technical systems engineering representative.
Qualifications / Requirements
Master’s degree in systems engineering, Electrical Engineering, Computer Engineering, Software Engineering, Biomedical Engineering, or related field.
Minimum 5+ years of experience in systems engineering, product development, or technical leadership for complex products.
Experience developing regulated products using formal design controls and quality management processes.
Strong understanding of medical device development lifecycle, including requirements engineering, architecture, risk management, design verification, validation, and product release.
Experience working with multidisciplinary engineering teams across hardware, software, systems, and cloud technologies.
Experience defining and managing system requirements, interfaces, and traceability throughout the development lifecycle.
Desired Characteristics
Experience developing diagnostic imaging systems, including ultrasound digital products.
Experience designing and integrating cloud-connected medical devices, SaMD, remote service solutions, or digital healthcare platforms.
Understanding of ultrasound imaging architectures, networking, cybersecurity, edge computing, AI/ML integration, and healthcare interoperability standards.
Experience leading system design for distributed solutions involving imaging scanners, edge devices, cloud infrastructure, web/mobile applications, and enterprise healthcare systems.
Strong systems thinking and ability to manage complex cross-functional technical dependencies.
Excellent communication and stakeholder management skills, with ability to influence technical and business decisions.
Demonstrated ability to lead architecture discussions, design reviews, and technical decision-making.
Proven ability to deliver innovative products in a highly regulated environment while balancing technical, clinical, regulatory, and business needs
Inclusive & Diversity Paragraph
GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.
Behavior Statement
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.
Total Reward Statement
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Additional Information
Relocation Assistance Provided: No