Senior Engineer, New Product Development

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Ensuring the successful development and integration of all next-generation THV balloons projects into their respective THV balloon expandable delivery system program.
• Creating, managing, and communicating the technical strategies required to integrate NPD balloons projects into their respective NPD programs, ensuring projects are successfully developed and delivered per program level requirements.
• Developing process validation strategies and participate in validation execution in conjunction with the commercial manufacturing sites for all NPD balloon project.
• Driving process DFM, process FMEAs, and mistake proofing analysis and implementation for balloons.
• Collaborating on balloon test method development.
• Driving manufacturing process design and characterization, work on a strong cross-functional team, and partner with the commercial sites on process validations and commercialization activities across multiple NPD programs simultaneously
• Providing experience across all phases of the development cycle from concept through to commercialization and all types of NPD projects from Early Human Use / Clinical through to next generation Commercial.
• Partnering with Operations and Supply Chain at the Pilot and Commercial manufacturing sites to ensure successful transfer and release of Clinical and Commercial balloon projects from NPD.
• Participating in balloon design and specification development.

What you’ll need (Required)

• A Bachelor's degree in Engineering or Scientific field; preferably Mechanical or Biomedical.
• A minimum of 4 years of engineering experience including NPD experience in medical device industry.
• Travel up to 15%.  

What else we look for (Preferred)

• Six Sigma Black Belt Certification.
• Familiarity with DFM and LEAN.
• Previous experience in a manufacturing support role.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Strong project management skill.

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 $101,000 to $142,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.