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Skills: Medical Device Design, Nitinol Implants, FEA, Abaqus, SolidWorks
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Full-time
bachelor degree
Posted 37d ago
~40 hrs/week
Responsibilities
Lead the design, optimization, and testing of the Innovalve heart valve implant within the TMTT product group. Manage development efforts for clinical studies and collaborate with manufacturing to ensure seamless production transitions.
Requirements
Requires a B.Sc. in Mechanical Engineering and at least 5 years of experience in medical device design, specifically with Nitinol implants. Proficiency in CAD software and a strong understanding of mechanical engineering principles are essential.
Full job description
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 be part of the valve R&D team and contribute to the development of a novel device that will revolutionize the treatment of cardiovascular diseases.
How you will make an impact:
As an engineer in the valve R&D team, you will provide expertise in design, optimization and testing of the Innovalve heart valve implant as part of the product development
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 new innovative design concepts
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 5 years of experience in medical device design and development.
Strong understanding of mechanical engineering principles, including materials science, stress analysis, and manufacturing processes.
Experience designing Nitinol implants
Experience with FEA and Abaqus software – Advantage
Analytical, problem-solving, and critical thinking skills.
Great attention to detail and organizational skills.
Experience with regulatory requirements
High verbal communication skills.
High proficiency in English and Hebrew
Proficiency in CAD software (SolidWorks or similar).
Ability to work independently and as part of a cross-functional team
Willingness to travel abroad 2-3 times a year
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.
Global leader in the medical device industry with a patient-focused culture of innovation
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1958
Headquarters
Irvine, CA
LinkedIn followers
424,545
Edwards Lifesciences (NYSE: EW), 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.
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.
Contact Us
We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus
If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.
All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Medical DevicesHeart ValvesSurgical MonitoringStructural Heart DiseaseHealth Care TechnologyHeart InnovationsMedical InnovationsHeart Valve TechnologiesHeart Valve TherapiesTranscatheter Mitral &Tricuspid Therapies
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