Product Analysis Engineer, I - St. Jude Medical
The St. Jude Medical Product Analysis Engineer I major responsibilities include:
• Supply and analyze product analysis data for trends and opportunities for improvement.
• 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
• 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.
• Develop and document standard operating procedures and test procedures
• Automated test setup with Labview
• Develop testing such as Accelerated Testing (HALT) Equipment, Structural Test Equipment, or equivalent.
Analyze current testing and make improvements.
• 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 ananlysis data to utilize for design and process improvements.
Job Knowledge / Experience Required:
• Bachelors Degree in Engineering, applicable Technical Field or documented and proven equivalent experience
• 1-2 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
Other Desirable Qualifications:
• Good written and oral communication skills
• Work cross-functionally with minimal supervision
• Experience in a regulated industry is desirable
• Data analysis knowledge is desirable
• ASQ CQE or similar certification
• Six Sigma Green Belt or Black Belt certification a plus
• With the guidance of the Product Analysis Manager, lead and direct the daily activities of the Failure Analysis Technicians
• Prioritize the workflow of the Failure Analysis Technicians and make adjustments as necessitated by business needs