Lead Systems Engineer - Medical Devices

Lead System Designer Job Description Summary Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation. Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.). Job Description Roles and Responsibilities Lead systems engineering activities for the development of next-generation medical devices, defining system requirements, architectures, interfaces, and end-to-end workflows across hardware, software, cloud, and connectivity components. Drive product definition and system design from concept through commercialization, ensuring alignment with customer needs, clinical workflows, regulatory requirements, and business objectives. Own requirements management and traceability, translating 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 software, hardware, cloud, cybersecurity, quality, regulatory, clinical, manufacturing, and product management teams throughout the product development lifecycle. Lead risk management activities in accordance with ISO 14971, including hazard analysis, risk assessment, risk control implementation, and verification of risk mitigations. Ensure compliance with applicable medical device standards and regulations, including: ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management) IEC 62304 (Medical Device Software Lifecycle Processes) IEC 62366 (Usability Engineering) IEC 60601 Series (Medical Electrical Equipment Safety) IEC 81001-5-1 (Health Software Cybersecurity) FDA, MDR, and other global regulatory requirements as applicable Drive design reviews and technical reviews across all phases of development, ensuring readiness for phase gates and regulatory submissions. Partner with Verification & Validation teams to establish comprehensive V&V strategies, ensuring designs are testable and requirements are fully traceable to objective evidence. Oversee development and maintenance of Design History Files (DHF), system specifications, architecture documents, interface definitions, risk files, and other design control deliverables. Support regulatory submissions, inspections, audits, and design reviews as the technical systems engineering representative. Lead integration activities involving imaging scanner subsystems, cloud platforms, networking components, AI/analytics capabilities, and enterprise healthcare ecosystems. Drive cybersecurity-by-design, privacy-by-design, and secure development practices for connected medical devices and cloud-enabled healthcare solutions. Mentor engineering teams on systems engineering best practices, design controls, risk management, and medical device compliance requirements. Required Qualifications Bachelor's or Master's degree in Systems Engineering, Electrical Engineering, Computer Engineering, Software Engineering, Biomedical Engineering, or related engineering discipline. Minimum 5+ years of experience in systems engineering, product development, or technical leadership roles 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. Knowledge of global medical device standards and regulations including ISO 13485, ISO 14971, IEC 62304, and IEC 62366. Experience defining and managing system requirements, interfaces, and traceability throughout the development lifecycle. Preferred Qualifications Experience developing global medical imaging products such as CT, MRI, PET, Ultrasound, X-Ray, or other diagnostic imaging systems. Experience designing and integrating cloud-connected medical devices, Software as a Medical Device (SaMD), remote service solutions, or digital healthcare platforms. Understanding of imaging scanner architectures, networking, cybersecurity, edge computing, AI/ML integration, and healthcare interoperability standards. Experience with FDA, EU MDR, Health Canada, NMPA, PMDA, or other international regulatory frameworks. Familiarity with cybersecurity standards and secure product development practices for medical devices. Experience leading system design for distributed solutions involving: Imaging scanners Edge devices Cloud infrastructure Web and mobile applications Enterprise healthcare systems Desired Characteristics Strong systems thinking and ability to manage complex cross-functional technical dependencies. Excellent communication and stakeholder management skills, with the ability to influence technical and business decisions. Demonstrated ability to lead architecture discussions, design reviews, and technical decision-making. Strong analytical and problem-solving skills with a focus on patient safety, product quality, and user experience. Proven ability to deliver innovative products in a highly regulated environment while balancing technical, clinical, regulatory, and business needs. Inclusion and Diversity: GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviours: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. 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. #Everyroleisvital #LI-MP2 Additional Information Relocation Assistance Provided: No Experience Level Senior Level