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V&V Engineer- Israel

ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our smART+™ platform is an intelligent, sensor-based feeding system for critical care patients that aims to prevent life-threatening in-hospital complications such as ventilator-associated pneumonia, malnutrition and acute kidney injury. With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the smART+™ platform monitors, analyzes and prevents malnutrition and gastric aspiration in real-time. By providing optimal nutritional care and achieving up to 100% feeding efficiency, the smART+™ platform improves the standard of care and helps ICU patients recover faster.

We are looking for talented Validation and Verification engineer to join our collaboration team.

Role & Responsibilities

  • Responsible for verification and validation tests plans with the ability to maintain and cross-reference it with risk analysis matrix
  • Develop and maintain test methods, equipment and instruments and regression tests for medical device throughout all development and production stages of the product
  • Performing validation and testing of hardware (mechanical, electronic implantable devices) and SW for prototypes and products
  • Design, selection and documentation of test equipment
  • Formulate test guidelines, Acceptance Tests procedures, protocols, and tests reports
  • Participate and lead engineers in designing features and requirements
  • Coordinate V&V tests at external laboratories (such as: Safety, EMC, transportation, etc.)

Requirements

  • B.Sc. degree in Biomedical, Mechanical, Electrical engineering or equivalent experience.
  • 2+ years of experience in planning, writing & executing test plans and protocols, in medical device industry with a strong emphasis on quality assurance, problem solving, along with written and verbal skills.
  • Proven technical, analytical, problem-solving and troubleshooting skills.
  • Prior work in a regulated environment, following development standards and processes.
  • Formal and practical knowledge of testing methodologies.
  • Good documentation skills and ability to communicate effectively at all levels of the organization.
  • Familiar with Medical Device Quality Systems, ISO 13485.

Apply Here








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