Director Research and Development

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.