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WHAT
IN
Product Performance Engineer
Job
Medtronic
US
-
Santa Ana,
California
Job Code - 69745
Position - Full Time - Regular
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Medtronic for this position!)
JOB DESCRIPTION: Product Performance Engineer
Apply engineering and statistical principles to evaluate product performance to improve the safety, reliability and maintainability of products and systems. Interpret complaints with associated analysis results, initiate and monitor trends of failure and complaint patterns as they emerge based upon statistical analysis. Establish and maintain trending triggers and standards for product performance. Develop and execute necessary plans for integrated reliability testing activities to ensure product reliability and overall product goals are met. Provide leadership in areas of process engineering, product quality assurance and quality engineering to drive continuous process and product improvements.
REQUIREMENTS - QUALIFICATIONS: Product Performance Engineer
At the appropriate point during post commercialization, work to ensure a smooth transition of product Quality responsibilities from DAE to the Post Market Product Assurance group (reliability/performance metrics reporting, etc).
•Prioritize timely completion of complaint investigations, CAPA decisions, and DHR reviews, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
•Initiates discussions with management, Field Assurance, and QA via the product quality meetings when new failure mode trends are identified, providing field performance data as it becomes available.
•Develop and maintain a robust process for identifying and monitoring root cause failure modes, frequency, and severity. Provide statistical data to Field Assurance, QA, and management on product peformance, effectively describing clinical observations and the relationship with device performance.
•Represent QA in product Risk Analysis updates for assigned products.
•Maintain, monitor and report trend analysis information on assigned products.
•Provide direction for failure analysis technicians to ensure that field returns are evalated appropriately to deliver clear results and potential root causes for identified failures.
•Function as the contact point between Field Assurance and QA.
•Conduct all engineering activities in compliance with FDA's Quality System Regulation, MDD, ISO 13485, Canadian CMDR, and other quality and regulatory requirements and standards.
•Co-manage returned product analysis and failure investigation activities for manufactured products.
•Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
•Deliver constructive feedback and provide quality leadership in a cross-functional environment.
BS in Engineering or equivalent, plus 3+ years of QA experience required.
•Proven excellent technical writing skills, strong analytical and critical thinking skills, and strong interpersonal communication and presentation skills are required.
•Experience with basic reliability analysis, industrial statistics Business Objects and/or Excel.
Medtronics
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