Lead Architect, Heart Failure Management Systems

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits package

Job summary

Edwards Lifesciences in California seeks a Senior Distinguished Engineer to drive technical strategy for the Implantable Heart Failure Management platform, overseeing implantable MEMS sensors, patient devices, clinician software, and hospital systems from concept through commercialization.

You will mentor engineers, shape long-term technology vision, lead design controls, verify and validate for Class II/III devices, and partner with R&D, Operations, Supply Chain and Regulatory to enable

Qualifications

• Bachelor’s degree in Engineering or Science with 15 years of experience as a technical leader for complex medical device platforms.
• Demonstrated success 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 our Heart Failure Management platform, including implantable MEMS sensors, patient devices, clinician software, and hospital-based and calibration systems.
• Establish and drive the manufacturing technology strategy for complex heart failure therapies, enabling successful product commercialization, manufacturing scalability, operational excellence, and advancement of next-generation manufacturing capabilities.
• Define and advance manufacturing and operational strategies through Design for Excellence (DFx), automation, process validation, quality engineering, and scalability initiatives.
• Serve as the senior technical SME for complex engineering challenges, root cause investigations, process transfers, supplier changes, audits, and regulatory submissions.
• Champion innovation and new technologies to improve product capabilities, manufacturing performance, and operational efficiency across the portfolio.
• Influence cross-functional decisions and technical roadmaps by partnering with R&D, Operations, Supply Chain, Quality, Regulatory, Clinical, and external manufacturing partners.
• Mentor and develop engineering talent, establishing technical standards, sharing expertise, and elevating organizational capabilities.
• Shape the long-term technology vision for Heart Failure Management systems, identifying opportunities to accelerate innovation, reduce risk, and deliver meaningful patient impact.

Skills

Technical leadership

Systems engineering

Medical device

Implantable sensors

Software-enabled systems

Regulatory knowledge

DFx

Cross-functional leadership

Education

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

Job description

Edwards Lifesciences in California seeks a Senior Distinguished Engineer to drive technical strategy for the Implantable Heart Failure Management platform, overseeing implantable MEMS sensors, patient devices, clinician software, and hospital systems from concept through commercialization.

You will mentor engineers, shape long-term technology vision, lead design controls, verify and validate for Class II/III devices, and partner with R&D, Operations, Supply Chain and Regulatory to enable