Senior NPD Quality Engineer – Medical Device Innovation

Regulatory Jobs; Irvine (CA); Presencial; USD 108.000 - 153.000; Tempo integral

Benefícios oferecidos por esta vaga

Competitive salary

Performance-based incentives

Benefits programs

Resumo da vaga

Edwards Lifesciences in California seeks a Quality Engineer to apply design control, risk management, and regulatory compliance across the product lifecycle. You will partner with R&D, manufacturing, and cross-functional teams to ensure safe, effective therapies and robust quality systems for cardiac surgery technologies.

We value strong communication, problem solving, and leadership, with opportunities to influence design transfers, testing, CAPA, and continuous process improvement within a

Qualificações

• Bachelor's Degree in Engineering or Scientific field with 4 years’ related industry experience.
• Master's Degree or equivalent in Engineering or Scientific field with 3 years’ related industry experience or industry/education experience.
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Responsabilidades

• Develop, update, and maintain design control documentation through product development processes.
• Develop, update, and maintain technical content of risk management and usability files
• Collaborate with R&D, manufacturing, and other cross-functional stakeholders to drive process and/or test method development, product builds, clinical programs, design transfer, and product launch. Participate in design verification and validation testing.
• Investigate complex product quality and compliance issues during new product development based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and RandD processes using SIX Sigma and LEAN methods for design for manufacturing and continuous process improvement.
• Assign support tasks; give instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership

Conhecimentos

Problem solving

Leadership

Communication

Analytical thinking

Formação

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Ferramentas

MS Office Suite

MS Project

CAD

Descrição da vaga

Edwards Lifesciences in California seeks a Quality Engineer to apply design control, risk management, and regulatory compliance across the product lifecycle. You will partner with R&D, manufacturing, and cross-functional teams to ensure safe, effective therapies and robust quality systems for cardiac surgery technologies.

We value strong communication, problem solving, and leadership, with opportunities to influence design transfers, testing, CAPA, and continuous process improvement within a