About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: The Safety and Regulatory Engineer will work with cross-functional program team to deliver mobile C-arm X-ray products for the global market., This role will be responsible for the safety and regulatory related design requirement clarification and flow down, involve in product design and verification to ensure the product meet the global regulatory requirement.
Essential Responsibilities: Duties include (but are not limited to): • As member of program team to define product regulatory requirement, and flow down to subsystem and component design requirement. • Working with global team to track the regulatory change of regions and countries, analyze change impact, drive corresponding design update or field actions. • Working with design engineer to review design solutions from the safety and regulatory perspective, involve in design FMEA, risk management. • Working with third party test lab to perform product type test, submit product registration. • Involve in system verification and validation, design and execute test protocol and summarize test result.
Qualifications/Requirements: 1. Bachelor degree or above major in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or other closely related discipline. 2. Bachelor 5+ years, Master 3+ years working experience in product development and testing. 3. Good working experience in product certification, registration and 3rd party test. 4. Familiar with medical device standards and product registration process. 5. Excellent teamwork, coordination and communication skills
Desired Characteristics: 1. Good experience in medical product registration or safety design, especially in X-ray, CT, DSA. 2. Effective communication skill in English, global project experience will be plus. 3. Self-starter, energizing, results oriented, and able to multi-task. 4. Demonstrated technical leadership capability in integration activities
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