Company Name: Konica Minolta Healthcare
Position Title: X-Ray R&D Program Manager
Location: 2217 U.S. Hwy 70 E, Garner, NC 27529
Summary of Duties: Responsible for the program and program management for the research, design, and development of our X-Ray equipment, while providing installation and servicing support for our equipment, and training and technical support to our customers, dealers, and field engineers. Provide project management to align with market opportunities, the company's product road map, and organizational goals. Drive cross-functional planning and execution of projects for new product development and sustaining engineering activities. Ensure optimal performance by tracking project execution metrics including monitoring project scope, schedules, resources, and quality. Conduct technical investigations to provide the highest level of customer satisfaction. Participate in systems engineering design, prototype development, and testing. Develops design specifications and test methods based on customer requirements. Work closely with sales and customer service departments to ensure customer satisfaction. Diagnose technical equipment by conducting root cause analysis and propose improvement solutions. Maintain tools and test equipment properly, and ensure timely calibration. Complete all required project and design control documentation in accordance with company policies, procedures, and regulatory requirements. 3 days per week required in-office; 2 days work from home. Telecommuting permitted within a reasonable distance of the Garner, NC office location.
Qualifications: Master's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a closely related field, and three (3) years of experience in medical device design and commercialization or related role. Employer will also accept a Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a closely related field, and five (5) years of experience in medical device design and commercialization or related role. Must also have Two (2) years' experience with: X-ray technologies; Leading projects for development of X-ray systems; Design control (MDSAP and ISO 13485); Risk management (ISO 14971); Usability of medical devices related to safety (IEC 62366); and X-ray physics and fundamental diagnostic X-ray imaging. One (1) year of experience with: Project management.