Lead the development of innovative medical devices and bring them to market.

We are seeking a passionate Senior R&D Engineer to champion the development and commercialization of our medical devices.
You’ll play a pivotal role in bringing groundbreaking technology to patients, ensuring it meets the highest standards for safety and efficacy.

What you’ll do:

• Spearhead the entire development process for medical devices, guiding them from concept to successful market launch.
• Foster close collaboration across cross-functional teams, including Regulatory Affairs, Quality Assurance, Clinical Affairs, and Manufacturing, to ensure seamless project execution and successful outcomes.
• Champion regulatory compliance throughout the product lifecycle, guaranteeing adherence to design controls, all applicable regulations, and industry standards.
• Author high-quality documentation for compliance purposes, including protocols, reports, and submissions for regulatory requirements.
• Conduct hands-on testing and evaluations of designs, design changes, and verifications to ensure their safety and effectiveness.
• Clearly communicate project status, potential risks, and achievements to senior management and stakeholders.

Who you are:

• Hold an advanced degree (Ph.D., M.Sc., or B.Sc.) in Biomedical Engineering, Mechanical Engineering, or a related field.
• Possess a minimum of 5 years of experience in medical device R&D and/or product management, with experience in Class III devices a plus.
• Demonstrate a proven track record of leading successful product development projects and securing regulatory approvals, preferably including PMA (Premarket Approval) experience.
• Have a comprehensive understanding of Design Controls, FDA regulations, and ISO standards.
• Excel in project management, adeptly handling multiple projects simultaneously while maintaining focus.
• Possess strong analytical and problem-solving skills with a keen eye for detail.
• Communicate effectively in writing and interpersonally, fostering strong collaboration across internal teams and external partners.
• Fluency in English is mandatory; proficiency in Hebrew is a plus.

Join us and make a meaningful difference in the field of medical technology!

Key Benefits:

• Competitive salary and benefits package
• Opportunity to work in a dynamic and innovative environment
• Access to professional development and career advancement opportunities
• Contribute to the development of cutting-edge medical technology that improves lives
• Gain invaluable experience in obtaining FDA PMA approval