Impactful Quality Engineer II, New Product Development

Edwards Lifesciences; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Edwards Lifesciences in California is seeking a Quality Engineer to apply quality engineering principles to ensure regulatory compliance and to optimize product development, internal and external device manufacturing, and distribution.

You will develop and validate complex test methods, maintain risk management files, collaborate with R&D and Clinical Development, and drive continuous improvement using SIX Sigma and LEAN, while ensuring high integrity and safety across the product lifecycle.

Qualifications

• Bachelor's Degree in Engineering or Scientific field and 2 years’ related work experience OR
• Master's Degree or equivalent in Engineering or Scientific field including industry or industry/education
• Experience with test method development and validation

Responsibilities

• Develop and validate complex test methods to create, validate, and improve products and manufacturing processes based on engineering principles; analyze results, make recommendations, and develop reports.
• Develop, update, and maintain technical content of risk management files
• Work closely with R&D and Clinical Development to collaborate on project deliverables and meeting timelines
• Engage on design assurance and reliability related activities
• Investigate manufacturing product quality and compliance issues (CAPA, non-conformances, audit observations) for all production processes before final release
• Optimize manufacturing processes using SIX Sigma and LEAN methods for design for manufacturing and continuous process improvement
• Develop training and documentation materials for production to enable knowledge transfer
• Assign support tasks; instruct technicians on tests; coordinate technician work
• Other incidental duties assigned by Leadership

Skills

Documentation skills

Communication skills

Interpersonal skills

Negotiation

Relationship management

Problem solving

Analytical thinking

Attention to detail

Team collaboration

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Job description

Edwards Lifesciences in California is seeking a Quality Engineer to apply quality engineering principles to ensure regulatory compliance and to optimize product development, internal and external device manufacturing, and distribution.

You will develop and validate complex test methods, maintain risk management files, collaborate with R&D and Clinical Development, and drive continuous improvement using SIX Sigma and LEAN, while ensuring high integrity and safety across the product lifecycle.