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Quality Assurance Engineer (Electrical)

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ORGANIZATION: ArdenMed

  • 1 person is 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 designed to address the specific challenges of developing countries. These devices will be distributed on a charitable basis. For our Mission we need your help. If you are motivated by the description below, we encourage you to apply for this opportunity using our internal system at http://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=16&request=136

Your Impact
When we walk into a hospital we all assume that we can trust the medical devices literally with our lives. However, ensuring that such reliability is justified is hard work. In many developing countries this type of trust is not at all obvious. It is our dream that those who need treatment can have trust in the medical industry regardless of where they live. In this position, you will be helping us to achieve exactly that. You will:

  • Improve the safety and reliability of the device
  • Provide context on the intended use and possibilities of misuse
  • help us achieve FDA and MDR approval

Your Responsibilities

  • Work with the Risk Manager, Mechanical Engineers, and Medical Professionals to specify device requirements
  • Write verification/validation plans in compliance with -FDA requirements
  • Review and write requirement documents
  • Review design documents
  • Plan and organize hardware tests and trials

Requirements

  • Significantly involved in compliance work on a medical device with successful
    FDA submission or equivalent experience in another high-quality industry
  • 1+ year professional experience in electrical engineering
  • expertise in working with international standards
  • ideally, experience with Test Management using XRay and Jira

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 ArdenMed

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

CAUSE AREAS

Emergency & Safety
Health & Medicine
Emergency & Safety, Health & Medicine

WHEN

Thu Apr 21, 2022 - Tue Jun 21, 2022

WHERE

This is a Virtual Opportunity with no fixed address.

SKILLS

GOOD FOR

N/A

REQUIREMENTS

  • Required Weekly Time Commitment: 8h+
  • Electrical Engineering, IEC60601 Electronical Medical Devices, Medical Devices, FDA / MDR Submissions, Quality Control,

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