Principal Clinical Development Engineer at Edwards Lifesciences Corporation Japan

Ramat Gan, Tel-Aviv District, Israel -

Full Time

Start Date

Immediate

Expiry Date

01 Aug, 26

Salary

0.0

Posted On

03 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Engineering, Bio-medical Engineering, Product Development, SolidWorks, CAD, Root Cause Analysis, Complaint Handling, Quality Assurance, Regulatory Requirements, ISO 13485, FDA QSR, Materials Science, Stress Analysis, Manufacturing Processes, Technical Reporting, Risk Management

Industry

Medical Equipment Manufacturing

Description

Edwards Lifesciences is growing and our R&D Engineer position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Innovalve team, as part of Edwards’ transcatheter mitral and tricuspid therapies (TMTT) product group. Innovalve Bio Medical Ltd. was acquired by Edwards in July 2024, enhancing the company’s 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 an R&D Engineer, Provides expertise in the optimization of product development for the Innovalve delivery system and accessories. Design and Development: Design, analyze, and develop components and processes that meet stringent quality, performance, and regulatory requirements. Problem-Solving: Identify and 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, data collection and custom testing setup development. Analyze investigation data to determine probable 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, and align on conclusions and next steps. Follow up on complaints arising from clinical cases (e.g., case questions, device performance observations) and provide timely technical input to R&D, QA and Clinical Development teams. Collaborate with cross-functional partners to define and implement corrective actions addressing issues identified through investigations. Support change management activities (e.g., ECOs) and contribute to risk management updates as needed based on investigation learnings. Clinical procedure experience – Advantage What you’ll need: B.Sc. in Mechanical engineering or Bio-medical engineering Minimum of 5 years of experience in relevant field. 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. Proficiency in English and Hebrew knowledge in CAD software (SolidWorks, or similar). Experience with regulatory requirements (e.g., ISO 13485, FDA QSR). Experience with medical devices development and quality documentation 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 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. Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path! 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 or have a valid religious or medical exemption from being vaccinated. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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Responsibilities

The engineer will lead product investigations for returned medical devices, perform root cause analysis, and develop technical solutions for the Innovalve delivery system. They will also collaborate with cross-functional teams to ensure compliance with quality and regulatory standards throughout the product lifecycle.