Senior Distinguished Engineer, Heart Failure Manufacturing

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 191,000 - 271,000; Full time

Job summary

Edwards Lifesciences in California is seeking a Senior Distinguished Engineer to drive technical strategy for our Heart Failure Management portfolio, including implantable sensors, patient devices, and software platforms.

This role leads product development, process validation, manufacturing transfer, and regulatory submissions, partnering across R&D, Operations, Quality, and Regulatory to deliver scalable, clinically meaningful solutions.

Qualifications

• Bachelor’s degree in Engineering or Science with 15+ years of experience as a technical leader.
• Experience leading new product development, process development, validation, and manufacturing transfer.
• Willingness to travel up to 25% domestically and internationally.

Responsibilities

• Provide technical leadership and system ownership for Heart Failure Management platform.
• Define and advance manufacturing and operational strategies including DFx, automation, process validation, quality engineering, and scalability initiatives.
• Serve as the senior SME for complex engineering challenges, root cause investigations, process transfers, supplier changes, audits, and regulatory submissions.
• Mentor and develop engineering talent, establishing technical standards and elevating capabilities.

Skills

Technical leadership

Systems engineering

Medical devices

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

PhD or Master’s degree

Job description

Edwards Lifesciences in California is seeking a Senior Distinguished Engineer to drive technical strategy for our Heart Failure Management portfolio, including implantable sensors, patient devices, and software platforms.

This role leads product development, process validation, manufacturing transfer, and regulatory submissions, partnering across R&D, Operations, Quality, and Regulatory to deliver scalable, clinically meaningful solutions.