Quality and Regulatory Engineer :

ISO 13485 and CE certification

Starting Date: Now
Location: Bordeaux
Keywords: Echocardiography, Medical device, Software, ISO 13485,  EN 62304, CE marking
Education: BSc, MSc, PhD. Formation in Software Development

Context: 

DESKi, “learn” in Breton, is a young and innovative company, combining a strong expertise in both echography and artificial intelligence. After 2 years of research, we developed real-time AI-driven algorithms able to guide inexperienced operators performing cardiac ultrasound (see video link). 
Deski is now building HeartFocus, a solution for remote and decentralized echocardiographic exams. Heartfocus App uses our guidance AI driven algorithmes to help non-expert acquire ultrasound images at the point of care (i.e. where and when needed). Those images are then transferred to Heartfocus WebPlatform for a remote interpretation by cardiologists.

Mission:

As a member of DESKi Team, you will be in charge of implementing the quality system of DESKi following the norm ISO 13485 and obtaining the CE certification for the solution HeartFocus. For the certification and the regulatory affairs, DESKi will be supported by an external and specialized company. 

Requirements:

  • 3y+ experience in quality and regulatory  development

  • Experience in ISO 13485 (including EN 62304) and CE certification

  • Quality and Regulatory of medical Software

  • Proficiency in english

Desired skills:

  • Experience in agile development

  • Experience in GDPR

  • Informatics background

  • Medical Background

  • Understanding of ML/AI

Your application includes:

  • Cover letter detailing your motivation

  • CV

To be sent to contact@deski.io
Please reach out if you have any questions !

logo bleu BL.png

All Rights Reserved ®