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 by:

　　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

　　Learn new software as required

　　Participate in cadaver and animal studies as required

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

　　What you'll need (Required):

　　Bachelor's Degree in Scientific field (e.g. Engineering, Computer Science, etc.).

　　Minimum 2 years of experience OR

　　Master’s Degree (Internship, senior projects, or thesis in Engineering or Scientific field).

　　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 is preferred

　　Knowledge in cardiovascular science and heart disease processes

　　Well-organized: accustomed to high standards of written and verbal communication and maintaining excellent records of correspondence

　　Ability to operate effectively in a culturally diverse organization and with global teams.

　　Good presentation skills; ability to present material comfortably. Good teamwork, networking, communication (written/verbal) and win-win relationship building skills

　　Ability to build stable working relationships internally

　　Ability to work positively through confrontation and/or conflicting ideas

　　Basic understanding of statistical techniques

　　Candidate is required to fully comply with all US and Global regulations, and SOPs in the execution of all job duties

　　Quick learner; ability to come up to speed quickly on Edwards’ products and service.

　　This position is fully on-site and based out of Irvine, CA. Must live within a commutable distance or be able to relocate.

　　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).

　　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.

　　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.