Senior Quality Engineer, NPD — Life-Saving Medical Devices

Regulatory Jobs; Irvine (CA); Presencial; USD 108 000 - 153 000; Tempo integral

Resumo da oferta

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer, NPD to support the Transcatheter Heart Valve (THV) program. You will lead design control documentation, risk management files, and cross-functional design transfers to enable successful product development.

The role requires collaboration with R&D and manufacturing, and the ability to address complex quality and regulatory challenges. Candidates should have a relevant engineering or scientific degree with several years of

Qualificações

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

Responsabilidades

• Develop, update, and maintain design control documentation through product development processes.
• Develop, update, and maintain risk management and usability files.
• Collaborate with R&D, manufacturing, and other cross-functional stakeholders to drive design transfer and product launches; participate in verification and validation testing.
• Investigate complex product quality and compliance issues during new product development and provide recommendations.
• Identify opportunities to optimize manufacturing and R&D processes using Six Sigma and LEAN methods.

Conhecimentos

Cross-functional collab

Leadership

Problem solving

Written/verbal comms

Formação académica

Bachelor's in Engineering/Science

Master's in Engineering/Science

PhD in Engineering/Science

Ferramentas

MS Office

MS Project

CAD

Descrição da oferta de emprego

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer, NPD to support the Transcatheter Heart Valve (THV) program. You will lead design control documentation, risk management files, and cross-functional design transfers to enable successful product development.

The role requires collaboration with R&D and manufacturing, and the ability to address complex quality and regulatory challenges. Candidates should have a relevant engineering or scientific degree with several years of