During these uncertain times, how can we help?

As the world leader in volunteerism we feel a responsibility to unite our broader community, and to use this moment to become stronger.

See below to access our COVID-19 Resource Hub, and to explore our growing directory of COVID-19-specific and virtual volunteering opportunities.
Read More
 

Medical Compliance Manager for remote pandemic ventilator

Save to Favorites

ArdenVent

  • 3 people are interested
Image_202006280529

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.

This is a great opportunity for somebody who wants to work with a dedicated team of engineers and providers to create groundbreaking technology. You have the opportunity to directly impact the quality and safety of this technology by following mostly simple (but long) instructions from regulatory bodies such as the FDA. You will get the chance to become highly qualified in the design and development process of medical devices which can be directly applied to the process in any other industry except for the much greater clarity to be gained in this field. For any engineer, experience with this level of process control and coordination is a highly valuable experience for your CV.

Status report:
We are finishing off some design elements of the mechanical parts of our system and finalizing the first iteration of our software. We have made a reasonable start with documenting our design and implementing the required document, quality and design control for medical approval and acquired tools that will support and automate the process. However, a lot still needs to be done

Description:
Since we plan to operate internationally we need a solid understanding of the most common medical regulations. Although the first iteration of the device should be considered a first-aid emergency device we are specifying it's functionalities for much more than that and ultimately in a future iteration would like to achieve ICU approval. Furthermore, there are not only mechanical safety regulations but we also must consider biometric data acquisition, data security, data privacy and software architecture regulations. As a result of this opportunity the equipment will be accepted much more readily among clinicians but we will also receive significantly more funding which will directly lead to many more lives protected.

Tasks:

  • assemble and lead a small team of volunteers to support you in the remaining tasks
  • research regulatory aspects in our initial target countries but also from the FDA
  • communicate the requirements with the developers
  • create documentation in conjunction with the developers to be handed to regulatory institutions
  • Approve and Quality Control documents handed to regulatory institutions
Training and/or experience required:
  • 5+ years of work experience
  • Experience with industrial design control or medical regulatory compliance ideally with the FDA
  • Ability to perceive technical details
  • International viewpoint and ability to research foreign compliance regulations.
  • Management and Leadership experience
  • Good Communication skills

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

53 More opportunities with ArdenVent

2 Reviews

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$150 - US$200

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
  • Legal (General)
  • Contract Negotiations
  • Law Enforcement

GOOD FOR

N/A

REQUIREMENTS

  • 10h+ per week

Report this opportunity