Director, Device Performance Monitoring

Working independently and in consultation with the Director, Senior Quality Assurance has primary management responsibility directly or through lower management levels for the functional areas of the Postmarket Performance Monitoring Group. This Group is comprised of the Product Returns Analysis, Product Reporting, and Patient Tracking functional groups. Works closely with other sources of non-conformances (e.g. Technical Services, Scientific/Clinical Studies) and incorporate into product reliability metrics. Integrates all relevant sources of non-conformances, provides trends of key issues, and drives teams to effective resolutions. Plans and directs operations ensuring that Corrective Action and Preventive Action (CAPA) and Risk Management protocols are followed/deemed valid and returns are examined/documented carefully to meet regulatory requirements. Responsible for the generation of Product Performance Reports that summarize the survival probabilities of our product line. Assures that quality of services meets internal and external customer requirements. Maintains a safe working environment and a strong customer focus. Exercises judgment in planning and organizing work; monitors performance and reports status. Sets goals, ensures that they are met and is responsible for continuous process improvement. Uses best business practices to ensure success in areas of responsibility. Qualifications:A Bachelor’s Degree in Engineering, Science, a related field, or equivalent. Typically a minimum of at least ten plus years of progressively more work experience in high technology product/failure analysis and reliability is required. Requires highly developed leadership skills/people-management experience sufficient to assume the complex range of personnel issues inherent in this position. A minimum of four plus years of demonstrated experience at a supervisory/managerial level is typical. Seasoned judgment acquired through wide experience and cross-organizational assignments. The ability to work cooperatively/productively with others is also required. Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this senior management position, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be adept at delegation, follow-up, and team building. Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations. Comprehensive verbal and written analytical/problem solving, communication, negotiation, interpersonal, training and presentation skills are essential. Documented record of delivering information that adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Demonstrated verbal and written communication, interpersonal and presentation skills; the ability to lead a cross-functional team. Proficient personal computer skills including spreadsheet skills, word processing, data base management, and other relevant applications. Desired Requirements: An advanced credential in a relevant discipline/concentration. Professional certification or designation. Previous experience in failure analysis as well as seasoned judgment acquired through organizational experience in the medical device industry is highly desirable. Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), cycle time improvement, and various technical applications as noted above.Requisition # 8364APPLY NOW! St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.