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.
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
If you feel you have the knowledge and skills necessary to assist with this position and you are interested in volunteering with us, please apply directly through our organization here: https://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=11&request=100
Brigham Creek Rd 174, Hobsonville, Auckland 0618, NZ
Our mission is to maximize the efficiency and effectiveness of the world's medical workforce fighting COVID-19
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. Our equipment will be distributed on a "what you can pay" basis. Our Ventilator is different from other emergency Ventilators in that it will be controllable over the Internet, with the medical professional observing the patient over a phone camera, thus reducing viral load on the medical professionals at the front line, enabling those in stable countries to help and allowing one doctor to have an overview over many patients.
Our Ventilator is now in testing and we are finalizing fine air control. Parts cost for a single unit are 300$ but will drop in mass production and bulk ordering maybe even down to 200$.
Our roadmap consists of 4 Versions which can be deployed over the internet. It is envisaged that the Ventilator will be assembled by qualified volunteers, go through centralized quality control and then distributed to places of greatest needs on an international basis. Once enough funding is raised, a part of the workload will be outsourced to specialized companies.
Computers & Technology
Health & Medicine
We'll work with your schedule.
This is a Virtual Opportunity with no fixed address.