Edwards Lifesciences Quality Engineer II in Irvine, California
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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.