מחקר

System Engineer

145689

תאריך עדכון

09/09/2020

תיאור המשרה

A medical device company operating in the field of Ophthalmology is seeking to hire an engineer to join our V&V and R&D activities.

 

Responsible for all aspects of medical device product development from concept to manufacturing 

In charge of all elements of design control and documentation: 

Risk management, planning, design input/output, verification & validation, change control, specifications, SOPs, test protocols, records and reports (STD, test protocols, STR).

Create and maintain a Design History File (DHF) and Device Master Record (DMR). 

  

  • Leading the V&V process plan  , test protocols, tests execution, results analysis and test report       
  • Responsibility for implementing V&V procedures in accordance with the work instructions.       
  • Design and implement experiments for various projects.       
  • Lead verification and validation efforts for new products and components.       
  • Document experiments / testing methodically including result summary  , analysis and interpretation.       
  • Writing system documentation - Take part in preparations of technical quality reporting documentation.       
  • Participate in defining and executing R&D programs.       
  • Assist the production activities as needed.       
  • Logistic support to marketing activities. 

Reports to VP of R&D

 

Requirements:       

  • Apply “systems” thinking and knowledge of systems (SW+HW).       
  • Quality assessments of product and development practices, compliance with all FDA requirements and IEC 60601 standards, EMC and ESD. Support ISO 13485 certificate.       
  • Minimum of a Bachelor of Science Degree in Electrical Engineering with at least 10 years’ experience with all aspects of medical device product development, design control and verification & validation for medical devices, from planning to execution.       
  • Excellent verbal and written communication       
  • English at native level
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