Failure Investigation Engineer

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

The Failure Investigation Engineer will be relied upon as an expert with in-depth technical knowledge of all aspects of Cepheid products. In this position, they will lead, perform and document investigations to determine root causes of various failures. They will evaluate and recommend corrective actions 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
  • Work with cross functional teams to support new product and process introductions
  • Use product software and other software tools as part of testing
  • Develop new test methods and tools, and validate them for failure investigation use
  • Continuously document progress during investigations and prepare final reports
  • Prototype and evaluate potential mitigations and corrective actions
  • 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 Bioengineering, Biomedical Engineering, Process Engineering or equivalent experience
  • Minimum of 5-8 years relevant professional experience
  • 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 independently and cross-functionally to provide effective updates at executive level
  • Ability to successfully lead multiple investigations simultaneously within short deadlines
  • Excellent organizational and communication skills (oral and written)
  • Excellent writing and documentation skills
  • Experience with statistical analysis and data management for large volume complex data sets
  • Experience working in a manufacturing environment and/or within manufacturing operations under cGMP, ISO and FDA regulations

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