
Senior Staff Systems Designer
GE HealthCare · Posted Oct 27
Medical technology, pharmaceutical diagnostics, and digital health solutions provider
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About the role
GE HealthCare is a global medical technology and digital solutions innovator focused on improving lives through healthcare technology. The Digital Cardiovascular Ultrasound team develops digital cardiovascular ultrasound products, with systems engineering covering requirements, architecture, integration, verification and validation, risk management, and manufacturing support. This role leads end-to-end systems engineering across the medical device lifecycle, from concept through commercialization and post-market support.
What you will do
- Lead end-to-end systems engineering activities for digital cardiovascular ultrasound products throughout the medical device development lifecycle, from concept through commercialization and post-market support.
- Own the definition, development, and delivery of product features and clinical applications, including requirements management, architecture development, design analysis, integration, verification, validation, and risk management.
- Drive technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements.
- Lead cross-functional development teams across engineering, clinical, quality, regulatory, product management, manufacturing, service, and marketing organizations.
- Ensure effective requirements flow-down and traceability from customer and clinical needs to subsystem and component-level specifications.
- Conduct system design trade-off analyses and make data-driven decisions that balance performance, reliability, manufacturability, serviceability, scalability, and cost objectives.
- Lead design control activities including FMEA, hazard analysis, verification and validation planning, reliability testing, defect prevention, and corrective and preventive actions (CAPA).
- Serve as the primary systems engineering representative for internal and external audits, regulatory submissions, product reviews, and compliance activities.
- Provide technical leadership and mentoring to systems engineering teams, influencing program priorities, development strategies, and execution plans across multiple product generations.
- Collaborate closely with global stakeholders to resolve complex technical challenges, manage dependencies across subsystems, and ensure seamless product integration and customer satisfaction.
- Support manufacturing, field service, and customer issue resolution activities, driving root cause analysis and continuous product improvement initiatives.
Skills used in this role
What the employer is looking for
- Bachelor’s or master’s degree in engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related STEM discipline.
- Minimum of 8+ years of engineering work experience in product development
- Minimum of 6+ years of experience with systems engineering, product development, and design control processes within the medical device or healthcare technology industry.
- Strong understanding of medical device development lifecycle, requirements management, risk management, verification and validation, and regulatory compliance.
- Experience leading cross-functional product development teams and complex technical programs.
- Knowledge of system architecture, subsystem integration, software-hardware interactions, and clinical workflow development.
- Strong analytical, problem-solving, communication, and stakeholder management skills.
- Cloud-native and hybrid cloud/on-premises product development using AWS services.
- Containers, Kubernetes, CI/CD, Infrastructure as Code and production observability.
- Secure engineering, identity and access management, encryption, secrets management and DevSecOps.
- Performance, scalability, availability, reliability, fault tolerance and disaster recovery.
- Automated unit, integration, API, system, performance and reliability testing.
- Strong design, coding, debugging, root-cause analysis and technical documentation practices.
- Integration challenges of third party and second party SaaS solutions.
- Working with AI-DLC and software development acceleration.
- Experience in regulated healthcare or medical-device development is required for the Verification Lead and strongly preferred for senior architecture, automation and program roles.
- Strong knowledge on SDLC, PRD process, Risks, FMEAs.
- Awareness of patient-data privacy, cybersecurity and secure handling of clinical information.
- Knowledge of healthcare interoperability standards such as DICOM, HL7 and FHIR.
- Experience with real-time clinical data, device connectivity, patient monitoring or high-availability clinical applications is advantageous.
Preferred qualifications
- Demonstrated experience in systems engineering methodologies in healthcare product development.
- Expertise in FMEA, reliability engineering, and healthcare quality management systems.
- Demonstrated successfully leading new product introductions and multi-generational product development programs.
- Working knowledge of FDA, MDR, IEC 60601, IEC 62304, ISO 14971, and related medical device standards.
- Proven ability to influence technical strategy, mentor engineering teams, and drive execution across global organizations.
Benefits and support
- Compensation and benefits are detailed in the job posting
About GE HealthCare
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator dedicated to providing integrated solutions, services, and data analytics. Spun off from General Electric, the company serves patients and healthcare providers globally through its advanced imaging, ultrasound, patient care solutions, and pharmaceutical diagnostics segments. It focuses on driving precision care, improving hospital efficiency, and advancing clinical outcomes worldwide.
- Industry
- Medical Devices
- Company size
- 54000 employees
- Founded
- 2023
- Location
- Chicago, Illinois, USA
- Funding stage
- Public Company
Funding
Public Company
Leadership
President and Chief Executive Officer
Chief Financial Officer
Chief Science and Technology Officer
General Counsel & Corporate Secretary
Global Chief AI Officer
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