Senior Quality Engineer – New Product Development / Design Assurance (THV) – Edwards Lifesciences – Irvine, CA

This Senior Quality Engineer 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.

Key Responsibilities:

• Supports New Product Development in the areas of Quality Assurance, Design Assurance, Design Controls, Risk Management, and Statistical Techniques.
• Leads design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.) for New Product Development programs
• 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 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 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 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

Required Qualifications :

• Bachelor’s Degree in Engineering or Scientific related field with 4 years of Quality Engineering, Quality Manufacturing, and/or R&D experience; OR Master’s Degree in Engineering or Scientific related field with 3 years of Quality Engineering, Quality Manufacturing, and/or R&D experience
• Experience in investigating and resolving design-related challenges
• Experience with leading Test Method Development and Validation
• Knowledge and experience with Risk Management (e.g. FMEA/dFMEA)
• Engineering experience within a highly regulated industry

Preferred Qualifications:

• Bachelor’s or Master’s degree in Mechanical, Materials, or Chemical Engineering.
• Experience within Medical Device, Pharma, or Biotech industries.
• Quality Engineering experience in New Product Development/Improvement (Class III devices preferred).
• Design Control Activities (e.g. Design Verification & Validation, Design Deviations, and/or Failure Investigations for Testing)
• Experience partnering with R&D and/or Sustaining organizations to provide support for product testing
• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• In-depth understanding of statistical techniques
• Strong understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Ability to manage competing priorities in a fast-paced environment

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