• 10 people are interested
 

Quality Assurance Engineer (Software)

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ORGANIZATION: ArdenMed

  • 10 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 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 software engineering
  • expertise in using Test Driven Development (TDD) or Behaviour Driven Development (BDD)
  • ideally, experience with GitHub actions and continuous integration tools
  • 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!

WARNING YOUR APPLICATION WILL NOT BE PROCESSED UNLESS YOU APPLY THROUGH THE LINK

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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

Every Year 4.2 million children under 5 are desperate for oxygen. 800,000 mothers lose their child every year because of Pneumonia, a lung disease often requiring oxygen. This toll is higher than for any other disease in the world. What hospitals in the US and Europe consider one of the most essential treatments is not available for many. The problem, oxygen concentrators keep breaking down in the high humidity, temperature and dust environments, burn through during energy spikes when the power comes back online after one of the many outages or simply breaks and nobody knows how to repair it.

We have set out to change this and develop an oxygen concentrator that will make public health investments much more effective. Our first calculations suggest that we could lower the cost of a child's life by as much as two-thirds. Due to our organization working with volunteers we can reduce the development cost but bringing a medical device to market is hard work and we expect that you meet the requirements and are responsive and transparent with your skills and availability. If our mission sounds important and exciting to you, learn more about us on www.ardenmed.com and apply for one of our open positions through our platform! http://jira.ardenmed.com/plugins/servlet/loginfreeRedirMain?portalid=16&request=136

CAUSE AREAS

Health & Medicine
Health & Medicine

WHEN

We'll work with your schedule.

WHERE

This is a Virtual Opportunity with no fixed address.

SKILLS

  • Software Engineering
  • Legal (General)

GOOD FOR

N/A

REQUIREMENTS

  • Required Weekly Time Commitment: 8h+
  • Software Engineering, C++ Programming

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