Product Analysis Engineer - St. Jude Medical, Plano, TX

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

Supervisory Requirements:

• 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

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