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  • 12 people are interested
 

QA Engineer for remote ventilator

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ArdenVent

  • 12 people are interested
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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!

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About ArdenVent

Location:

Brigham Creek Rd 174, Hobsonville, Auckland 0618, NZ

Mission Statement

Our mission is to maximize the efficiency and effectiveness of the world's medical workforce fighting COVID-19

Description

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 Ventilators in that it will provide the doctors with powerful automation infrastructure and be fully 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.

Given the rapidly deteriorating situation in India, we are currently focusing our efforts on the development of a low-cost, high-efficiency oxygen concentrator but are continuing our ventilator development as well.

Our Ventilator is now undergoing some changes that are required for medical compliance in our target countries. Parts cost for a single unit are US$300 but will drop in mass production and bulk ordering maybe even down to US$200. The oxygen concentrator is estimated to cost between US$300 - US$500

Computers & Technology
Crisis Support
Health & Medicine

WHEN

We'll work with your schedule.

WHERE

This is a Virtual Opportunity with no fixed address.

SKILLS

  • Software Engineering
  • System Engineering
  • Mechanical Engineering

GOOD FOR

N/A

REQUIREMENTS

  • 10h+ per week

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