Product Program Manager RAD and Change Management
GE Healthcare
GE Healthcare
Join GE HealthCare, a pioneer in medical technology and digital solutions, dedicated to creating a world with limitless healthcare. This role leads Product Program Management for RAD subsystem products, specifically X-Ray Tubes and X-Ray Generators, integral to mobile and fixed radiography systems. You will drive engineering design changes and oversee the Product Life Cycle Management for these critical components. Your focus will be on enhancing installed-base product performance, improving quality, reliability, regulatory adherence, cost, and delivery. Leveraging installed-base data, you'll establish reliability targets and champion Design for Reliability principles for new product introductions.
Oversee the field and factory performance of RAD Tubes and Generators, concentrating on quality, reliability, compliance, cost, and delivery. Monitor performance trends, analyze field and reliability data using statistical methods like Weibull analysis, and lead investigations into customer complaints and field failures. Partner with cross-functional teams including System Engineering, Field Engineering, and Service for technical support and issue resolution. Support New Product Introductions (NPIs) by setting reliability targets and contributing to Risk Management activities, including DFMEA/PFMEA. Maintain essential documentation such as Technical Files and Design Control records to ensure QMS compliance. Drive product lifecycle initiatives and chair Engineering Change Control Board (ECCB) reviews to implement timely and compliant engineering changes.
This position requires a Bachelor's, Master's, or PhD in Electrical and Electronics or Mechanical Engineering, coupled with at least 8 years of engineering experience, ideally within medical devices, medical imaging, X-Ray products, or other regulated industries. Proven experience in Installed Base Engineering, Engineering Change Management, Design Controls, Risk Management, and Product Lifecycle Management is essential. Strong skills in field performance monitoring, failure analysis, root cause analysis (RCA), reliability engineering, and statistical data analysis are required. Familiarity with Weibull analysis, B10/B50 life estimation, reliability target setting, Design for Reliability, and relevant medical device and X-Ray product safety standards (IEC 60601, ISO 13485, ISO 14971) is expected. Experience with QMS and Design Control tools, supplier change management, and structured problem-solving tools is also necessary. A Six Sigma Green Belt certification is preferred. Strong leadership, analytical, and collaborative skills are key to success in this role.
GE Healthcare
IT Consulting