Quality and Regulatory Engineer :
ISO 13485 and CE certification
Starting Date: Now
Keywords: Echocardiography, Medical device, Software, ISO 13485, EN 62304, CE marking
Education: BSc, MSc, PhD. Formation in Software Development
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.
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.
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
Experience in agile development
Experience in GDPR
Understanding of ML/AI
Your application includes:
Cover letter detailing your motivation
To be sent to firstname.lastname@example.org
Please reach out if you have any questions !