מהנדס/ת NPI מוצר מדיקל איזור קיסריה

• Works with Product Development and other stakeholders’ teams to create detailed design specifications and testing plans. Collaborates with customers and holds meetings to collect and analyze all requirements to prepare appropriate design strategies. • Defines end-to-end product workflow and product modes. • Perform FTA, responsible for SW\HW tools to make system performance analyze • Lead product integration activities (SW, Mech, Elect.) to validate customer requirements. • Conceptualize, design, prototype, test, and ship system or module features along with our product and engineering teams • Contributes to risk management file to ensure successful regulatory approval of the new product across our global markets • Responsible for defining System Performance requirements and ensuring design implementation and verification of performance features. • Develop novel system user interfaces and working procedures for product and clinic procedures • Conducts product human factors & usability validation activities in collaboration with RA and clinical engineering • Carries out field testing and bench-level testing. • Effectively troubleshoot the systems associated with the LabVIEW program, including the software and other aspects such as the host PC, sensors, motors, pumps, electrical junctions, etc. • Writing technical documentation: specs, verification procedures, reports. • Lead disposable and reusable product validations as sterilization, biocompatibility, cleanability, shelf life, safety, and essential performance specifications. • Manage local & overseas subcontractors. overseas subcontractors.