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Irvine, California, United States
Onsite
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 Distinguished Engineer serves as a technical visionary and subject matter expert, guiding the long-term strategy and advancement of implantable sensor technologies within Heart Failure Management. Rather than leading product research and development, this role focuses on optimizing manufacturing performance, enabling successful commercialization and product transfers, improving quality and reliability, and solving complex operational challenges across a multi-generational product portfolio.
How you’ll make an impact:
Own heart failure management implantable MEMS sensor end to end to new product introduction.
Drive complex design components, automated equipment, imbedded software and circuit tuning as it relates to manufacturability products and processes of the system all the way to commercialization.
Develop complex documentation for manufacturing such as drawings, SOPs, routers, pFMEAs at various levels of release. Assure drawing review processes and responsibility for tolerance stack up compliance. Responsible for fit testing of design parts and fixtures in alignment with next level manufacturing expectation from Pilot to Commercial.
Develop complex training and documentation materials such as functional testing of MEMS, full sensors, laser welding, wire bond, laser trimming, hermetic sealing and testing and complex circuit tuning.
Lead strategy, prioritization, and technical support for QST, pre DV, DV – SME to Pilot on root cause investigations for manufacturing processes.
Drive improvements and support new technology in development of manufacturing equipment engineering and tooling design for the team. Support advanced root cause analysis upon request to assess complaints, field failures, or supplier issues.
What you’ll need:
Bachelor’s degree in Engineering or Scientific fields with 12 years of experience providing technical leadership for highly complex electronic systems in a highly regulated environment.
Expertise in micro-electromechanical systems (MEMS) based technologies, signal processing, system integration, and product development.
Travel up to 25% domestically and internationally.
What else we look for:
PhD or Master’s degree in Bioengineering, Industrial Engineering, Material Science, Chemistry, Physics, or related.
Proven expertise in the application of MEMS sensors within complex medical device systems, from concept through commercialization.
Experience developing and commercializing implantable medical technologies, including cardiac rhythm management, diabetes management, neuromodulation, or other electronic therapeutic and diagnostic systems.
Strong knowledge of implantable device manufacturing, including sensor integration onto printed circuit boards (PCBs), packaging, and long-term reliability considerations for in vivo use.
Hands-on experience with advanced manufacturing and assembly technologies, such as laser welding, wire bonding, micro assembly techniques, and electronic testing methodologies.
Expertise in electronic system manufacturing, including PCB-level assembly, verification, validation, and production-scale testing.
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 $159,000 - $226,000 (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.
