R&D Engineer

Company Description

AquaPass Ltd. is a leading developer and manufacturer of innovative solutions designed for the treatment of fluid overload in patients with heart failure, renal failure, and lymphedema. Our proprietary non-invasive technology bypasses the renal system and is suitable for both hospital and home use. Clinical trials have demonstrated promising results for patients with chronic heart failure (CHF) and end-stage renal disease (ESRD), supporting the system's safety and efficacy.

Role Description – R&D Engineer

We are seeking a full-time, on-site R&D Engineer to join the Wearable Team at our Shefayim location. The R&D Engineer will be instrumental in the continuous development of our wearable device, focusing on both functionality and usability improvements for the next-generation product. This role involves hands-on prototyping, testing, documentation, and collaboration across R&D, manufacturing, and clinical teams.

Key Responsibilities:

• Lead and support design improvements of the current wearable system with a focus on enhanced usability, performance, and patient comfort.
• Plan, execute, and document verification and validation (V&V) activities, including lab and usability testing.
• Generate and maintain comprehensive documentation in compliance with ISO 13485 and FDA requirements, including Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
• Develop and update work instructions, assembly processes, and end-to-end testing protocols.
• Support the transition from development to manufacturing, including production activities and process improvements.
• Analyse data, troubleshoot technical problems, and iterate designs based on test outcomes and feedback.
• Effectively communicate findings and progress to internal stakeholders across technical and clinical domains.

Qualifications

• B.Sc. in Mechanical Engineering or Biomedical Engineering from an accredited university.
• Minimum 2 years of hands-on R&D experience in the medical device industry.
• Strong understanding of medical device development processes and regulatory frameworks (FDA, ISO 13485, CE).
• Proficient in SolidWorks.
• Demonstrated experience with writing technical documentation, including SOPs, assembly instructions, and test protocols.
• Proven ability to conduct structured V&V testing and generate compliant documentation.
• Excellent analytical thinking, problem-solving skills, and attention to detail.
• Strong verbal and written communication skills in English and Hebrew.
• Team-oriented mindset with a proactive and collaborative approach to cross-functional projects.