Senior Distinguished Engineer, Manufacturing, Heart Failure Systems

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

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits program variety

Equal Opportunity Employer

Job summary

Edwards Lifesciences seeks a Senior Distinguished Engineer to lead technical strategy for a multi-generational Heart Failure Management portfolio, including implantable sensors and patient devices. You will drive system ownership, manufacturing tech strategy, and cross-functional collaboration with R&D, Operations, and Regulatory.

The role emphasizes design for excellence, validation, and scalable manufacturing while advancing next-gen capabilities and clinical impact.

Qualifications

• Bachelor's degree in Engineering or Science with 15 years of technical leadership in complex medical device platforms.
• Experience leading product development, process validation, and manufacturing transfer.
• Willingness to travel up to 25% domestically and internationally.

Responsibilities

• Provide technical leadership and system ownership for the Heart Failure Management platform.
• Define and advance manufacturing and operational strategies for complex therapies.
• Mentor engineering talent and drive DFx, automation, and design controls.

Skills

Technical leadership

Medical device systems

Software-enabled systems

Implantable sensors

Class III devices

Manufacturing transfer

Systems engineering

Education

PhD or Master's degree

Job description

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Distinguished Engineer is a recognized technical authority and key leader in the development of innovative Heart Failure Management Systems. This highly visible role drives the technical strategy and execution of a multi-generational product portfolio, including implantable sensors, patient handheld devices, hospital implantation systems, and software platforms. Responsibilities span product development, process and test validation, manufacturing transfer, and commercialization, ensuring robust, scalable solutions that deliver meaningful clinical impact. How you'll make an impact: Provide technical leadership and system ownership for our Heart Failure Management platform, including implantable MEMS sensors delivery systems, 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.

What you’ll need:

Bachelor's degree in Engineering or Science with 15 years of experience serving as a technical leader for complex medical device platforms, including implantable sensors, Class III devices, software-enabled systems, and advanced manufacturing technologies from concept through commercialization. Demonstrated success leading new product development, process development, validation, and manufacturing transfer. Travel up to 25% domestically and internationally.

What else we look for:

PhD or Master's in Electrical Engineering, Software Engineering, Mechanical Engineering, Systems Engineering, or a related technical discipline. Deep expertise in cardiovascular and implantable medical device technologies, including heart failure, cardiac rhythm management, or remote patient monitoring systems. Proven leadership developing complex, connected medical device systems that integrate hardware, software, wireless communication, sensors, and clinical workflows. Strong systems engineering background with expertise in requirements management, risk management, Design Controls, and verification & validation for Class II and Class III medical devices. Demonstrated ability to balance clinical needs, technical performance, manufacturability, cybersecurity, and regulatory requirements throughout the product lifecycle. Experience within leading medical device organizations developing implantable, wearable, or software-enabled healthcare technologies. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $191,000 - $271,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.