Failure Investigation Engineer

Organization: 
Cepheid - US
Job Location: 
Sunnyvale , CA
Job Description: 

Perform and document investigations and analyses to determine root causes of failures in consumables used as part of DNA analysis systems. Evaluate and recommend corrective actions. A major emphasis is the mechanical and fluidic aspects of the product. Scope may also evolve to include leading of failure trending initiative to guide continuous process improvement.

- Support manufacturing activities for first-line investigations of product or process failures
- Conduct failure investigations elevated from customer field complaints
- Lead brainstorming and other root cause analysis techniques
- Design and execute experiments as part of investigations
- Coordinate support activities from other departments
- Use product software and other software tools as part of testing
- Develop new test methods and tools, and validate them for use
- Continuously document progress during investigations
- Prototype and evaluate potential mitigations and corrective actions
- Prepare final reports for each investigation
- Play a key role in Product Transfer - Failure Analysis team to support continuous improvement efforts of the company
- Analyze historical data to identify trends and areas for investigation
- Perform failure trending and analysis on key performance metrics and manage data for team review

- Bachelor's degree in Mechanical, Biomedical, Quality or Process Engineering or equivalent experience
- Minimum of 5-8 years relevant professional experience
- Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations.
- Ability to use MS Office and other tools for data presentation and analysis
- Excellent writing and documentation skills
- Ability to handle multiple project simultaneously with short deadlines
- Expertise in data analysis, physical inspection, metrology, design of experiments, test engineering and test automation including scripting, root cause analysis techniques and documentation of results
- Ability to work in a biosafety environment
- Experience with statistical analysis and data management for large volume complex data sets

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