Senior Engineer, Safety and Regulatory
- GE Healthcare
- Posted 5/8/2017 3:12:50 PM
- Job Function: Engineering/Technology
- Business Segment: Healthcare Imaging
Location(s): China; BeiJing; Beijing
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.
The Systems Engineer has design responsibility to deliver customer workflow, feature functionality, product quality, reliability, serviceability, manufacturability, regulatory, compliance, and cost. Activities include requirements development, traceability and flow down, architecture / system design and analysis, FMEA, developing/executing System Verification and Validation test procedures, and providing support to manufacturing and field issues.
Duties include (but are not limited to):
• Providing domain expertise to serve as the main integrator between the hardware and software functions to deliver the best high quality product
• Working across functions and team boundaries to define, design, and implement the next generation of products
• Own system safety and regulation requirement such as IEC/UL/GB/FDA/CFDA as well as other regulations in worldwide into the specific design requirement for design team.
• Own RAC(risk analysis and control) and CMT(cause mitigation table) maintenance.
• Take the responsibility for testing and certification with external NRTL(Nationally Recognized Testing Laboratories) such as UL, CSA, ITS, TUV and China test lab to get the qualified report.
• Manage & conduct all verification test internally related to safety and compliance verification.
• Support product RA on all submitted documents for countries clearance promote and enhance the safety & compliance design concept inside of engineering team.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
5. Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
1. Master/PhD degree in Electrical Engineering, Computer Science, Biomedical Engineering, Physics, or closely related discipline
2. At least 5 yeas relevant work experience in medical regulatory related field.
3. Product certification or product design knowledge and related experience.
4. Wireless registration related knowledge and experience.
5. Proven ability to develop timely and effective solutions for challenging design problems
6. Demonstrated ability to pursue tasks to completion
7. Good at making articulation document in English.
1. Medical device certification work background or experience
2. Xray knowledge and related experience
3. Good English reading and writing skills
4. Excellent verbal and written communication skills
5. Self-starter, energizing, results oriented, and able to multi-task
6. Demonstrated problem solving ability and results orientation
Locations: China; BeiJing; Beijing