QA Engineer for remote ventilator

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We are a non-profit organization building an infrastructure to develop, manufacture, distribute, and operate remote-controlled ventilators and oxygen concentrators that will also gather high-resolution treatment data for scientific research and treatment optimization for the treatment of COVID-19.


Status report:
We are about to finalize our final prototype of the ventilator and are looking for clinics to partner with for clinical trials. As a charity, we had a hard time gathering the necessary expertise to fully comply with QA requirements from the FDA. We have done our best of creating the proper documentation systems and began to fill in the required information but more work needs to be done. Our target countries have lower regulatory requirements, especially for trials but we still want to build the safest product possible within the time frame available and apply for full FDA approval eventually.

Description:
We need one or multiple Quality Assurance Engineers to assess the quality of specifications and technical design documents in order to ensure timely, relevant and meaningful feedback. you will be involved in planning and implementing strategies for quality management and testing.

Tasks:

• Write risk management and verification/validation plans in compliance with FDA requirements
• Review and write requirement documents
• Review design documents
• help implement software tests
• plan hardware tests and trials

Training and/or experience required:

• Significantly involved in compliance work on a medical device with successful FDA approval
• expertise with relevant standards
• ideally, experience with test automation using GitHub

Become part of our mission by filling out our application form at http://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=16&request=136

That others may breathe!