Senior Engineer, Medical Device New Product Introduction

Edwards Lifesciences Gruppe; Redhill (MD); Presencial; USD 108 000 - 153 000; Tempo integral

Resumo da oferta

Edwards Lifesciences is seeking a Senior Engineer for New Product Introduction to drive the commercialization of Class III transcatheter heart valve products. You will partner with R&D, Quality, Supplier Development and Operations to ensure scalable manufacturing processes and supplier readiness across global sites.

The role requires design transfer execution, validation activities, and collaboration with multiple functions. Travel up to 20% and onsite work in California are expected.

Qualificações

• Minimum 4 years of experience in NPI/NPD, manufacturing operations, design transfers, or process/equipment validation.
• Experience leading design transfer deliverables and supporting product commercialization.
• Strong collaboration across R&D, Quality, Supplier Development, and Operations.

Responsabilidades

• Lead commercialization of Class III implantable THV products and drive manufacturing readiness.
• Collaborate with R&D, Quality, Supplier Development, and Operations to ensure scalable transfer plans and validation strategies.
• Drive line and capacity expansion plans with demand planning and commercial groups for uninterrupted product supply.
• Harmonize transfer plans across pilot, sustaining, and international sites; identify and mitigate risks.
• Support MES deployment and implement robust control points in manufacturing.

Conhecimentos

NPI/NPD experience

Manufacturing operations

Design transfers

Process/equipment validation

Formação académica

Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related technical field

Ferramentas

Six Sigma

LEAN

cGMP

EH&S guidelines

Descrição da oferta de emprego

Edwards Lifesciences is seeking a Senior Engineer for New Product Introduction to drive the commercialization of Class III transcatheter heart valve products. You will partner with R&D, Quality, Supplier Development and Operations to ensure scalable manufacturing processes and supplier readiness across global sites.

The role requires design transfer execution, validation activities, and collaboration with multiple functions. Travel up to 20% and onsite work in California are expected.