Quality Engineer II

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

Job Function:

  • Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements.
  • Focus on Design Control, Design Verification, Design Validation, Specification Development, and Test methods.
  • Develop update, and maintain technical content of risk management files. Perform Failure Mode and Effects Analysis to identify product risks.
  • Apply statistical knowledge in developing Statistical Reliability tests and statistical sampling plans.
  • Critical review and approval of design specifications and design changes; partner with R&D in the design of safe and effective CC devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of CC devices
  • Identify and optimize complex manufacturing processes using engineering methods such as 6 Sigma and LEAN for design for manufacturing and for continuous process improvement. 
  • Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products
  • Evaluate failed devices, alternate components, materials and suppliers and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion

Required Education & Skills:

  • Bachelor's Degree in Engineering (Electrical ‘preferred’, Biomedical, or Mechanical) + minimum of 4 years of industry experience OR Master's Degree in Engineering + minimum of 3 years of industry experience
  • Strong understanding of FDA medical device regulations. Design Control knowledge is a plus
  • Must be able to work in a team environment, including inter-departmental teams. Ability to interact professionally with different functional groups including R&D, Regulatory, Operations, and Clinical Affairs. Experience working with R&D to affect design for manufacturing, mistake-proofing and robust design transfer to manufacturing
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
  • Knowledge of Electronics, IEC-60601 standard, and systems engineering are a plus.
  • Working knowledge and understanding of statistical techniques. Strong ability to identify, interpret, and apply statistical sampling methods. 
  • Ability to manage competing priorities in a fast paced environment
  • Strong problem-solving, organizational, analytical and critical thinking skills    
  • Ability to identify and describe quality system documentation components, including quality policies and procedures
  • CQE (Certified Quality Engineer) and 6 sigma Black Belt certification are a plus
  • Knowledge in using Quality Control Tools such as flowcharts, Pareto Charts, Cause and Effect diagrams is a plus. 
  • Demonstrate troubleshooting skills and capability in evaluating process changes and/or nonconformances for risk management or for developing technical justifications. 

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.