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we are looking for a Director, Quality QMS Compliance.
How you will make an impact:
Lead and oversee Quality Management System (QMS) activities at the Edwards Israel Innovation Center, including management review, audits, and CAPA.
Manage Quality objectives while ensuring Quality System compliance with Edwards QMS, ISO 13485 and FDA 21 CFR part 820 (QMSR).
Partner and collaborate with Operations, R&D and Project Management leaders to align and prioritize activities and to address quality issues.
Manage and mentor the Quality team, including the sub-functions of Quality Control, Document Control, and Equipment/Software V&V; foster a strong quality culture and team engagement.

we are looking for a R&D Technician (Contract).
As part of our R&D teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality.
Your purpose-driven work will help leave lasting and positive impacts on patient lives.
How you will make an impact:
Responsible for lab testing activities, such as:
Performing hands-on Tests, data collection, reports writing, equipment qualification, and additional R&D support
Developing new test systems and improving existing test systems together with R&D teams

we are looking for a Heart Valve Assembler.
As part of our assembly teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality.
Your purpose-driven work will help leave lasting and positive impacts on patient lives.
How you will make in impact:
Taking part in developing processes.
Assembly of valves and other devices under microscope for consecutive period of times.
Working in a controlled environment.
Solutions preparation.
Taking part in sterilization processes.
General lab work.

we are 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 transcatheter mitral and tricuspid therapies (TMTT) product group. Innovalve Bio Medical Ltd. was acquired 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 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

Required Sustain Mechanical Engineer
- Full technical ownership of assigned product lines across their lifecycle, serving as the senior engineering authority for sustaining activities
- Lead mechanical design changes in multidisciplinary products to improve quality, reliability, manufacturability, serviceability, and customer experience
- Drive cost-reduction initiatives (VAVE / Cost Down) through redesign of mechanical and electromechanical assemblies, materials, and manufacturing processes
- Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for field failures and production issues
- Provide ongoing engineering support to manufacturing and suppliers, including design optimization, tooling development, and first article inspections (FAI).