Principal NPD Quality Engineer — Medical Devices

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences is seeking a Principal Quality Engineer, NPD for Irvine, CA, to lead design controls and risk management across new transcatheter heart valve products. You will drive verification, validation, and manufacturing specifications while collaborating with cross-functional teams to ensure robust product launches.

The role requires strong technical leadership, experience in medical devices, and the ability to manage a team and travel up to 10% domestically and internationally.

Qualifications

• Bachelor’s Degree in Engineering or Scientific field with experience in design controls and risk management.
• Experience with FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366 is preferred.
• ASQ CQE or CSSBB or similar certifications are a plus.

Responsibilities

• Provide technical leadership for new product development projects from concept to launch.
• Lead risk management activities and maintain risk files for new products.
• Develop and validate test methods and design verification/validation activities.
• Collaborate with cross-functional teams to ensure transfer and launch of robust products.
• Lead investigations for product failures and implement corrective actions.

Skills

Design controls

Risk management

Statistical techniques

Project leadership

Cross-functional collaboration

Verification & Validation

Education

Bachelor’s degree in Engineering or Science

Master’s degree in Engineering or Science

PhD in Engineering or Science

Tools

MS Project

MS Office

Job description

Edwards Lifesciences is seeking a Principal Quality Engineer, NPD for Irvine, CA, to lead design controls and risk management across new transcatheter heart valve products. You will drive verification, validation, and manufacturing specifications while collaborating with cross-functional teams to ensure robust product launches.

The role requires strong technical leadership, experience in medical devices, and the ability to manage a team and travel up to 10% domestically and internationally.