Principal Clinical Development Engineer

Edwards Lifesciences isgrowingand ourR&DEngineer position is a unique career opportunity that could be your next step towards an exciting role will sit within theInnovalveteam as part of Edwards transcatheter mitral and tricuspid therapies (TMTT) product Medical Ltd. wasacquiredby Edwards in July 2024 enhancing the companys transcatheter mitral valve replacement (TMVR) technologies to address large unmet structural heart patient needs and support sustainable long-term growth.

This role offers an exciting opportunity to contribute to the development of innovative delivery systems and support clinical investigations and complaint handling partnering with QA and Clinical Development that will revolutionize the treatment of cardiovascular diseases.

How you will make an impact:

As anR&DEngineer Providesexpertisein the optimization of product development for theInnovalvedelivery system and accessories.

• Design and Development: Designanalyze and develop components and processes that meet stringent quality performance and regulatory requirements.

• Problem-Solving:Identifyand troubleshoot complex technical issues that arise during development and clinical trials.

• Custom Solutions: Develop tailored solutions for unique design challenges and clinical requirements

• Lead and perform product investigations for returned products and complaint samples including hands-on functional evaluation datacollectionand custom testing setup development.

• Analyzeinvestigation data todetermineprobable root cause and contributing factors using structured problem-solving methods (e.g. 5-Why Fishbone).

• Prepare clear technical summary reports and present investigation results to cross-functional teams; track actions to closure.

• Work closely with Quality Assurance to support complaint handling workflows ensure investigation documentation is complete andalign onconclusions and next steps.

• Follow up on complaints arising from clinical cases (e.g. case questions device performance observations) and providetimelytechnical input to R&DQAand Clinical Development teams.

• Collaborate with cross-functional partners to define and implement corrective actions addressing issuesidentifiedthrough investigations.

• Support change management activities (e.g. ECOs) and contribute to risk management updates as needed based oninvestigationlearnings.

• Clinical procedure experience Advantage

Whatyoullneed:

• . inMechanicalengineeringor Bio-medical engineering

• Minimum of5years of experiencein relevantfield.

• Strong understanding of mechanical engineering principles including materials science stress analysis and manufacturing processes.

• Analytical problem-solving and critical thinking skills.

• High verbal communication skills.

• Great attention to detail and organizational skills.

• Proficiencyin English and Hebrew

• knowledgein CAD software (SolidWorks or similar).

• Experience with regulatory requirements (e.g. ISO 13485 FDA QSR).

• Experience withmedical devicesdevelopment and qualitydocumentation

• Travel abroad 25% of the time

• Ability to work independently and as part of a cross-functional team

About TMTT Business Unit:
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 patients unmet clinical driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Every employee is essential to Edwards success andwereready to help you advance along your career path!

Edwards is committed tocomplying withthe 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 directlyinterfaces withpatients and those who interact with healthcare providers as part of their role. If hired as a condition of employment you willbe requiredtosubmitproof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.