Edwards Lifesciences is growing and our Principal Mechanical 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 that will revolutionize the treatment of cardiovascular diseases.
How you will make an impact:
As a Principal Engineer, Provides expertise in the optimization of product development for the Innovalve delivery system and accessories.
Manage current development and production efforts of current system running through EFS and IDE clinical studies
Concept Development: Collaborate with cross-functional teams to brainstorm, evaluate, and find innovative design concepts for delivery system components.
Design and Development: Design, analyse, 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.
Testing and Validation: Conduct rigorous testing and validation activities, including R&D testing, Design Verification (DV) testing, and clinical trial support.
Engineering Change Orders (ECOs): Initiate and manage ECOs to implement design changes and improvements.
Manufacturing Support: Collaborate with manufacturing engineering to ensure seamless transition of designs into production.
Custom Solutions: Develop tailored solutions for unique design challenges and clinical requirements
What you’ll need:
B.Sc. in Mechanical engineering
Minimum of 4 years of experience in medical device design and development.
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.
Ability to make decisions under pressure.
Great attention to detail and organizational skills.
Proficiency in English and Hebrew
Proficiency in CAD software (SolidWorks, Creo, or similar).
Experience with regulatory requirements (e.g., ISO 13485, FDA QSR).
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.
Top Skills
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
