The St. Jude Medical Product Analysis Engineer II major responsibilities include:
Major Ongoing Responsibilities:
• 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.
• Develop and document standard operating procedures and test procedures
• Automated test setup with Labview
• Develop verification and / or validation testing protocols on new and modified products- Analyze current testing and make improvements.
• Conduct detail oriented, data rich technical investigations regarding quality concerns
• 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.
• Help to evaluate mechanical, electrical, and thermal performance of components and systems
• Design and assemble test fixtures, load banks, and other components common to product development.
• 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.
• Supply and analyze product analysis data for trends and opportunities for improvement.
• Bachelors Degree in Engineering
• 5-10 years electrical / electronics / electromechanical experience
• 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
• Strong analytical and statistics skills
• Knowledge of the FDA QSR regulation and ISO13485.
• Knowledge or familiarity with Labview is a plus
• ASQ CQE or similar certification is desirable
• Six Sigma Green Belt or Black Belt a plus
• Good written and oral communication skills
• Work cross-functionally with minimal supervision
• Experience in a regulated industry is desirable