Senior Distinguished Engineer, Manufacturing, Heart Failure Systems

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

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.