R&D Engineer II - St. Jude Medical / Plymouth, MN Provide research and development (R&D) support for a wide range of diagnostic, imaging and ablation therapy cardiovascular catheters. Conduct feasibility studies and verify capability and functionality to support investigation and design changes. Develop solutions to improve product function and manufacturability. Direct support personnel and coordinate project activities. Responsible for managing design changes, requirement development, design verification testing/ data analysis, test method development/ validation and failure analysis. Responsible for writing and submitting Engineering Change Orders and supporting the development of risk management documentation (DFMEA, PFMEA and UFMEA) utilizing Product Lifecycle Management (PLM) software. Develop product requirements based on user needs and customer requirements. Maintain detailed documentation throughout all phases of a project. Responsible for investigating and evaluating design changes, manufacturing changes, Non-Conformance Material Report (NCMR), Corrective and Preventative Actions (CAPA) and customer complaints. Review and coordinate interactions and other activities with vendors to support product development. Research various cost-effective alternative approaches to current designs and manufacturing processes. Create test methods and develop fixtures for design testing purposes. Responsible for developing risk management documentation, including the design, process and use of Failure Mode and Effect Analysis (DFMEA, PFMEA, UFMEA). Responsible for creating and developing design test methods for the development of new and market released products, and performing Design Verification/Validation testing and data analysis for the proposed designs. Maintain and understand quality and regulatory organization requirements, Food & Drug Administration (FDA), American Society for Testing Materials (ASTM), International Organization of Standardization (ISO), and other industry relevant regulatory boards. Comply with FDA regulations and other regulatory requirements, as well as with organizational policies, operating procedures and task assignments. Responsible for providing necessary support to cross-functional project teams to meet project goals and deadlines. Bachelor s or foreign equivalent degree in Mechanical Engineering, Biomedical Engineering, Materials Science & Engineering or a closely related field of study with at least 1 year of experience in the medical device industry. Must possess experience in the following: (i) writing and submitting Engineering Change Orders and supporting the development of risk management documentation (DFMEA, PFMEA and UFMEA) utilizing Product Lifecycle Management (PLM) software; (ii) investigating and evaluating design changes, manufacturing changes, Non-Conformance Material Report (NCMR), Corrective and Preventative Actions (CAPA) and customer complaints; (iii) creating and developing design test methods for the development of new and market released products, and performing Design Verification/Validation testing and data analysis for the proposed designs; and (iv) quality and regulatory organization requirements, Food & Drug Administration (FDA), American Society for Testing Materials (ASTM), International Organization of Standardization (ISO), and other industry relevant regulatory boards. An EOE. 40 hrs/wk. Send Resumes to: Abbott Laboratories, Elvia Salazar, Willis Tower, 233 S. Wacker Drive, Floor 25, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0024-ES Refer to ID SJM-0024-ES when applying