Senior Heart Failure Systems Architect

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

Job summary

Edwards Lifesciences in California is hiring a Senior Distinguished Engineer to own the technical strategy for our Heart Failure Management systems, including implantable sensors, patient devices, and clinician software.

You will drive manufacturing technology, validation, and scalable processes, while serving as the senior SME for complex engineering challenges and regulatory submissions. A PhD or MS in a related field with 15 years of leadership is required.

Qualifications

• Bachelor’s degree in Engineering or Sciences with 15 years of leadership in complex medical device platforms.
• Experience leading new product development, process development, validation, and manufacturing transfer.
• Travel up to 25% domestically and internationally.

Responsibilities

• Provide technical leadership and system ownership for Heart Failure Management platform, including implantable sensors and patient devices.
• Establish and drive the manufacturing technology strategy for complex heart failure therapies.
• Define and advance manufacturing and operational strategies through Design for Excellence (DFx), automation, process validation, quality engineering, and scalability initiatives.
• Serve as senior technical SME for complex engineering challenges, root cause investigations, process transfers, supplier changes, audits, and regulatory submissions.
• Champion innovation to improve product capabilities, manufacturing performance, and operational efficiency across the portfolio.
• Influence cross-functional decisions and roadmaps by partnering with R&D, Operations, Supply Chain, Quality, Regulatory, Clinical, and external partners.
• Mentor and develop engineering talent, establishing technical standards and elevating capabilities.
• Shape long-term technology vision for Heart Failure Management systems and opportunities to accelerate innovation and reduce risk.

Skills

Technical leadership

Systems engineering

Design Controls

Verification & Validation

Cross-functional collaboration

Education

PhD or MS in Electrical / Software / Mechanical / Systems Engineering

Job description

Edwards Lifesciences in California is hiring a Senior Distinguished Engineer to own the technical strategy for our Heart Failure Management systems, including implantable sensors, patient devices, and clinician software.

You will drive manufacturing technology, validation, and scalable processes, while serving as the senior SME for complex engineering challenges and regulatory submissions. A PhD or MS in a related field with 15 years of leadership is required.