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Engineer II, Clinical Development

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Irvine, United States Edwards Lifesciences Full time

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Medical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. 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:

The Engineer II, Clinical Development (TMTT) will work with cross functional project teams in a unique opportunity to drive the clinical success of PASCAL within TMTT. A successful candidate will demonstrate knowledge of technical principles that can be applied to clinical procedure, imaging analysis, and engineering. This role will work closely with Edwards research and development (R&D) teams and quality teams as well as clinicians to develop and implement novel procedural improvements.

  • An ideal candidate will have the ability to think outside the box but also be detail oriented.

  • Clear communication, strong project management skills, and demonstrated good judgement are all key to this role.

  • Gaining expertise on TMTT therapeutic devices and the associated patient populations.

  • Learn basic echocardiography imaging modalities

  • Conduct root cause analysis and develop clinical procedure mitigations as related to field complaint investigations.

  • Design and develop models for procedural improvements, design improvements, root cause analysis, and physician training activities.

  • Support procedure planning through patient analysis, 3D modeling, and procedure review.

  • Present retrospective analysis learnings so that they can be transformed into procedural recommendations.

  • Up to 25% travel (1 to 2 times a month).

What you'll need (Required):

  • Bachelor's Degree in Engineering or Scientific field

  • 2 years experience OR

  • Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):

  • Good computer skills in usage of MS Office Suite & 3D Modelling (SolidWorks or equivalent) experience.

  • Technically strong background.

  • Medical Device Industry.

  • Experience in PASCAL and MitraClip technologies.

  • Strong time management skills.

  • Results oriented, positive “can do” attitude with a demonstrated a sense of urgency.

  • A “hands-on” individual who enjoys a challenge and is capable of getting the job done with minimal direction.

  • Good understanding of processes and equipment used in assigned work.

  • Must be able to work in a team environment, including immediate supervisor and other team members.

  • Experience with Therapeutic Implantable Devices or Interventional/Surgical Clinical experience.

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 $83,000 to $117,000 (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.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.