Senior NPD Quality Engineer - Medical Devices

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a high-caliber engineer to join the Implantable Heart Failure Management team. The role focuses on new product development with quality engineering leadership across design controls, risk management, verification and validation from concept through launch.

You will partner with cross-functional teams, drive test method development, support manufacturing transfers, and mentor direct reports while travelling up to 20% as needed.

Qualifications

• Must have engineering/science degree(s) and relevant experience.
• Strong knowledge of design control, V&V, and risk management.
• Experience with new product development in medical devices is preferred.

Responsibilities

• Provide technical leadership for NPD projects, applying design control and risk management.
• Collaborate with cross-functional stakeholders to align goals and drive actions.
• Lead risk management file updates for new products.
• Lead test method development and validation activities for new designs.
• Support transfer and launch of robust products with manufacturing teams.
• Manage/oversee a team of direct reports and develop talent.

Skills

Technical leadership

Risk management

Design Verification

Test method development

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in Engineering or Science

Master’s degree or equivalent

Ph.D. or equivalent

Tools

MS Office Suite

MS Project

Job description

Edwards Lifesciences in Irvine, CA is seeking a high-caliber engineer to join the Implantable Heart Failure Management team. The role focuses on new product development with quality engineering leadership across design controls, risk management, verification and validation from concept through launch.

You will partner with cross-functional teams, drive test method development, support manufacturing transfers, and mentor direct reports while travelling up to 20% as needed.