Senior Distinguished Engineer, Manufacturing, Heart Failure Systems

Posted 23 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
191K-271K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Lead technical strategy and system ownership for a multi-generational Heart Failure Management platform. Drive manufacturing technology, DFx, automation, process validation, and manufacturing transfer. Act as senior SME for engineering challenges, root cause investigations, audits, and regulatory submissions. Champion innovation, influence cross-functional roadmaps, mentor engineering talent, and shape long-term technology vision to deliver scalable, clinically meaningful implantable device solutions.
Summary Generated by Built In

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.

Skills Required

  • Bachelor's degree in Engineering or Science with 15 years of experience as a technical leader for complex medical device platforms
  • Experience with 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
  • Ability and willingness to travel up to 25% domestically and internationally
  • Strong systems engineering background including requirements management, risk management, Design Controls, and verification & validation for Class II and Class III medical devices
  • Master's or PhD in Electrical, Software, Mechanical, Systems Engineering, or related discipline
  • Deep expertise in cardiovascular and implantable medical device technologies, including heart failure or cardiac rhythm management
  • Proven leadership developing complex connected medical device systems integrating hardware, software, wireless communication, sensors, and clinical workflows
  • Experience within leading medical device organizations developing implantable, wearable, or software-enabled healthcare technologies
  • Demonstrated ability to balance clinical needs, technical performance, manufacturability, cybersecurity, and regulatory requirements throughout the product lifecycle

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Healthcare Strength Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
  • Retirement Support A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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