מדעים/ביוטק

Director Research and Development

117773

תאריך עדכון

29/03/2020

תיאור המשרה

Position Overview
 Reporting to the CEO, the Director, R&D will proactively drive product development, engineering, clinical and regulatory efforts required to successfully submit a device for regulatory approval. Responsibilities include developing and managing of parallel projects schedules for internal and external engineering teams to meet project timelines and company’s objectives.
  
 Key Responsibilities
  • Responsible for leading a medical device project through its entire lifecycle: specification and SOW development, creation of traceability matrix and risk management.  
  •  Manage complex schedules that involve both internal and external engineering teams, while prioritizing activities for rapid execution of critical path work items.  
  •  Manage the identification and development of mitigations for project risks.   
  • Lead team meetings, design/technical reviews, generate meeting minutes, task management and follow up action items to closure.   
  • Support the strategy of Regulatory and Clinical activities.   
  • Play key role in the development of the company’s QMS.
Mandatory Qualifications
  •  Minimum 10 years of experience in management and development of FDA class II and EU Class I and II medical devices involving algorithms, software and electronics hardware.   
  • 10 years of hands-on experience in development of software products and systems.   
  • Solid understanding of design controls and risk management.   
  • Solid experience in supporting preparation of technical files for regulatory submissions (US FDA and CE).   Strong program management experience working with R&D software engineering teams.   
  • Experience in C++ and Python.   
  • Experience in quasi real-time applications in Windows / Linux environment – an advantage.   
  • Proven experience in working with overseas partners / subcontractors.   
  • Understanding of all relevant standards to support medical device product development  
  •  Familiar with ISO13485   Excellent written and verbal communication skills in the English language.          
  • This position requires occasional travel.
  
 Education
 BS, MS in electrical engineering, computer science or biomedical engineering.
  
 
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