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.
Requirements: 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.
This position is open to all candidates.