Lead System Designer

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 Masters 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.

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 IECFDA 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

• Masters 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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.