Edwards Lifesciences Quality Engineer II (New Product Development/Improvement) - THV in Irvine, California
This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Provides engineering support in the areas of Quality Assurance, Design Controls, Risk Management, and Statistical Techniques.
Supports design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.) for New Product Development programs
Supports or leads test method development/validation activities for New Product Development programs.
Collaborates with the R&D and Sustaining organizations to help facilitate the successful execution of the NPD process and launching of robust products
Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
Develop, update, and maintain technical content of risk management files
Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership
Basic / Minimum Qualifications :
- Bachelor's Degree in Engineering or Scientific field, plus 2 years of experience in Quality Engineering or Quality Assurance.
Masters Degree in Engineering or Scientific field.
Current or prior experience within Medical Device, Pharma, Biotech, Aerospace, or Automotive industries.
Quality Engineering experience in New Product Development/Improvement (Class III devices preferred).
Knowledge and experience with Design Assurance, including Design Controls, Design Verification & Validation, and Design Test Method Development
Experience with device testing to ensure product will perform safely
Knowledge of and experience with Risk Management and Risk Management documentation
Experience partnering with R&D and/or Sustaining organizations to provide support for new product testing
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Ability to travel up to 10% (internationally)
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.