St. Jude Medical Engineer II, Quality Assurance in Plano, Texas

Engineer II, Quality Assurance

Plano, Texas, USA at

Engineering at

Global Operations-Supply Chain-Quality

160001S0Requisition #

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We are seeking an experienced, high caliber Failure Analysis Engineer II to perform duties in the Failure Analysis Lab within the Complaint process.

Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplishgoals.

Impact this role will have on St. Jude Medical:

  • Conduct detail oriented, data rich technical investigations regarding quality concerns

  • Provide technical expertise to the Product Analysis Laboratory

  • Analyzes failures, develops and implements investigative protocols to identify root causes, performs circuit analysis, performs device and component level failure analysis

  • Supply and analyze product analysis data for trends and opportunities for improvement.

  • Present analysis of trends in cross-functional monthly meetings with recommendations for actions and further analysis

  • Reviews Product Analyses Reports, approving closure of files that meet company and regulatory requirements

  • Maintain computerized complaint handling system and identify and implement corrective actions

  • Assist in the development of verification and / or validation testing protocols on new and modified products

  • Develop and document standard operating procedures and test procedures

  • Analyze current testing and make improvements including assisting in the development of Automated test setup

  • Any and all tasks specified by the Product Analysis Manager

  • Remain current on developments in field(s) of expertise, regulatory requirements, and a comprehensive knowledge of the company's products, markets, and objectives as well as industry trends

  • Resolve and/or facilitate the resolution of problems including identifying causes to prevent recurrence

  • Work cross-functionally with other departments, including product development, quality engineering, manufacturing engineering, and others, to effectively communicate analysis data to utilize for design and process improvements

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

  • Bachelors’ Degree in Engineering, applicable Technical Field or documented and proven equivalent experience

  • 3-5 years electrical / electronic / electromechanical experience

  • Ability to analyze electrical systems with focus on identification of failure mechanisms and associated root causes

  • Computer knowledge is essential (especially Microsoft Office Suite)

  • Demonstrated ability to understand and comply with applicable industry regulations and follows company operating procedures, policies, and rules is essential

  • Use test equipment such as oscilloscopes, volt meters, counters, microscopes, and data acquisition equipment

  • Ability to read electrical schematics

  • Strong analytical skills

  • Knowledge of the FDA QSR regulation and ISO13485

Your preferred qualifications and education:

  • Good written and oral communication skills

  • Work cross-functionally with minimal supervision

  • Experience in a regulated industry is desirable

  • Data analysis and statistical knowledge is desirable

  • ASQ CQE or similar certification

  • Six Sigma Green Belt or Black Belt certification a plus