Failure Analysis Engineer

Requisition ID
# of Openings


  • Perform investigation, failure analysis and implement corrective and/or preventive measures of material issue. Maintaining, updating and keep tracking with the SAP Quality Notification process.
  • Working closely with suppliers to ensure supplier quality standards are in accordance with Bio-Rad Requirements.
  • Managing material disposition, coordinating with supplier investigation report, engineering changes, definition of Procedures, Working instructions and Documents.
  • Review supplier, customer return disposition.
  • Achieve Manufacturing First Pass Test Yield targets.


  • Bachelor’s degree in Mechanical Engineering
  • More than 5 years of experience in discrete manufacturing environment, preferably in Life Sciences or Medical Device industries, held accountable for manufacturing yield targets, line stoppage avoidance, etc., for a few product lines at the same time.
  • More than 5 years of experience involving Mechanical Components (plastic, sheet metal, optics) preferred.
  • More than 5 years of experience in managing Engineering Change Requests/Orders.
  • More than 5 years of experience in performing failure analysis.
  • Knowledge in ISO 13485 requirements, risk management, pFEMA, Lean Manufacturing, 6 Sigma and SAP system.
  • Possesses excellent problem-solving, interpersonal, communication and leadership skills.
  • Advanced knowledge of quality tools, i.e. supplier assessments, First Article Inspections (FAI), Failure Modes Effects Analysis (FMEA), 8D Problem Solving, Root-Cause Analysis, Corrective Action, Mistake Proofing and Process Control.
  • Proven ability to work effectively in a team environment.
  • Ability to work under pressure, strict deadlines and work autonomously or under minimal supervision.
  • Knowledge of manufacturing processes such as injection molding, die-casting, machining, anodizing, passivation, plating and sheet metal fabricating.
  • Good understanding of mechanical drawings.


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