Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

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:

Designing, characterizing, and validating balloon molding processes using Lean, Design for Manufacturing and Six Sigma methodologies.Collaborating on test method development and balloon specification setting.Evaluating design concepts with respect to manufacturability.Driving process and equipment validations (ex. TFIQ, IQ, OQ, PQ).Leading manufacturing readiness activities for EHU/Clinical release products.Transferring balloon manufacturing from pilot to commercial manufacturing site.Deepening process knowledge and technical expertise of extrusion and balloon forming processes through process characterization.Developing manufacturing fixtures and tooling for process improvement and mistake-proofing.Drafting, approving, executing, and maintaining all relevant documentation (ex. SOPs, operator training, specifications, drawings, process sheets, FMEAs, and validation plans).Managing complex projects through phases of planning, execution, monitoring, and closure.Collaborating with cross-functional teams (ex., R&D, Quality, and Regulatory Affairs).Partnering with Operations and Supply Chain at the Pilot and Commercial manufacturing sites collecting VOF and ensuring successful Commercial device releases.

What you’ll need (Required):

A Bachelor's degree in Engineering or Scientific field (preferably Mechanical, Biomedical, Chemical Engineering, or Material/Polymer Science) with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required.

What else we look for (Preferred):

Familiarity with extrusions, plastics, and/or polymers manufacturing preferredStrong technical problem-solving and critical thinking skillsStrong project management and organizational skillsStrong verbal/written communication and interpersonal skillsProcess Development (Design, Characterization and/or Validation) experienceAbility to understand basic statistical techniquesAbility to analyze and solve complex problems via innovative thought and applied experienceAbility to organize and manage competing priorities in a fast-paced environmentAbility to work well independently as well as part of a teamAbility to interact professionally with all organizational levelsGood leadership skills and ability to influence changeFamiliarity with Design for Manufacturability and Lean Six Sigma preferredFamiliarity with Product Development process preferred

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 $103,000 to $146,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.