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Engineer II, NPD- Quality

Edwards Lifesciences · Irvine, CA

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QualityFull-time$87k–$123kCompany career page

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Role summary

Engineer II, NPD-Quality at Edwards Lifesciences develops and validates medical device products and manufacturing processes for cardiac surgery applications. The role involves quality engineering, risk management, process optimization, and cross-functional collaboration to support product development from concept through commercialization.

What they're looking for

  • Bachelor's degree in engineering or scientific field with 2+ years related work experience
  • Master's degree in engineering or scientific field with internship, senior projects, or thesis
  • CQE (Certified Quality Engineer) certification preferred
  • Experience with lab and industrial equipment
  • Strong documentation, communication, and interpersonal skills
  • Proficiency in statistical techniques and process improvement methodologies
  • Problem-solving, analytical, and critical thinking capabilities

What you'll be doing

  • Design and execute experiments and tests to validate and improve products and manufacturing processes
  • Develop and maintain technical content for risk management files and quality documentation
  • Investigate manufacturing quality issues and non-conformances; recommend corrective actions
  • Optimize manufacturing processes using Six Sigma and LEAN methodologies to improve efficiency
  • Create training and documentation materials for production knowledge transfer; supervise technician work

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