Sr Principal Engineer - Medical Devices Software/Hardwar

Sr Principal Engineer - Medical Devices Software/Hardwar Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Provide Quality oversight and guidance to project teams in area of responsibility, assuring compliance to procedure. Analyze data from various quality inputs (including, but not limited to: nonconformance, FCA, complaints, MDR, etc) to determine trends and systemic issues. Prepare and issue reports based on information analysis. Identify areas for product and system improvement, and interface with plant and corporate groups to ensure improvements are implemented. Develop and revise SOPs to support improvement efforts. Lead projects for improvements to the quality system as approved by management. Support CAPA and maintenance activities for existing product lines. Review and approve new and revised DHF and DMR documents and other records for the Quality function, including CAPA, V&V, Risk Management, etc. Provide training/guidance to Quality and Engineering personnel regarding compliance and statistical/analytical tools. QUALIFICATIONS: Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Effectively operate in and may facilitate cross-functional teams without guidance. Must be able to provide solutions that reflect understanding business objectives and cost implications. Knowledge of FDA, ISO, and MDD regulations. Project management and organizational skills. Problem solving and statistical analysis tools. ASQ CQE preferred. B.S. degree in Engineering and 9-13 years of experience, M.S. in Engineering and 5-7 years of experience or Ph.D. in Engineering and 3-5 years experience. Demonstrated success in delivering results on several technical challenges. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.