מהנדס/ת מערכת לחברת מדיקל מובילה קיסריה 225941

תיאור המשרה Develop Mechanical & Multidisciplinary modules from the initial concept to release as a part of the R&D department, with reference to medical device standards. Create system and modules design specifications and requirements, translating user needs to technical requirements. Create design and transfer to production documentation (DHF\DMR) following procedural development of medical products (Design Control). Responsible for creating and maintaining RMF (Risk Management File). Point of contact for R&D subcontractor’s activities: DR’s, Integration & Implementation in company products.Responsible for creating and maintaining RMF (Risk Management File). System aspects design in products portfolio: top-level architecture, new technologies implementation, define performance goals and tests, serviceability, interfaces specs, design to assembly and cost, human factors design. Responsible for product integration, reliability, qualification, environmental and safety tests in external LAB and in-house. Perform RCA (Root Cause Analysis) and drive outcoming system technical solutions to implementation through tests and data. Technical Leadership across project scope and the various company functions and resources. Support and cooperate with company departments (Regulatory, Service, Manufacturing, Engineering, Quality, and Marketing), being responsible for their early involvement during system design processes. Preparation of Risk Analysis and FMEA for system elements according to QMS. Lead system process validation activities. Availability to travel abroad and domestically.