Job Information
St. Jude Medical Cardiology Division Inc. Product Performance Engineer II in Plymouth, Minnesota
PRODUCT PERFORMANCE ENGINEER II St. Jude Medical, an Abbott Labs. Co. / Plymouth, MN Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the Corrective and Preventive Actions (CAPA) system . Analyze and investigate product complaints from the field as part of post market surveillance requirements. Communicate and educate management, R&D, marketing, sales organization and other departments, as well as external customers about product performance. Ensure information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing organizations as part of the risk management and design input systems. Develop Post Market Surveillance Plans and provide engineering support for complaint investigation readiness of new products. Analyze customer complaints, events and other post marketing surveillance data by examining the data for patterns/trends and investigating. Investigate customer complaints related to product quality or patient safety. Investigate identified trends by starting a formal trend investigation and trend report and working on cross-functional teams. Responsible for documenting trend actions by updating trend reports at appropriate levels and performing Health Risk Analyses . Communicate product performance by formal presentations to management committees and design teams. Support published product performance reports and customer requests for performance information either directly or through the sales organization . Develop test plans, procedures, justifications papers and provide engineering support for new product complaint readiness . Cultivate a wide range of internal networks and develop an extensive external network of resources to facilitate completion of tasks. Ability to lead project team of moderate scope and provide guidance to less experienced staff. Act as a mentor to lower-level individual contributors. Exercise authority and judgment within defined limits to determine appropriate action. Bachelor s degree or foreign academic equivalent in Industrial Engineering, Electronics Engineering or a closely related field of study with at least 2 years of experience in the following: (i) identifying, analyzing, investigating, monitoring and documenting patterns and trends in post marketing surveillance data as part of the Corrective and Preventive Actions (CAPA) system; (ii) documenting trend actions by updating trend reports at appropriate levels and performing Health Risk Analyses; (iii) supporting published product performance reports and customer requests for performance information; and (iv) developing test plans, procedures, justifications papers and providing engineering support for new product complaint readiness. An EOE. 40 hrs/wk. $74,506 - $120,000/year. 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-0033-ES.