Medical Device Quality/Regulatory Assurance
Helpful Engineering is seeking volunteers experts in Medical Device Quality/Regulatory Assurance. We have two volunteer positions open for experts in Medical Device Quality/Regulatory Assurance:
A QA/RA Lead for the Tetra project
Description: We are looking for a lead to make sure that our project complies with all best practices with respect to both quality and regulatory requirements. Our current device is a Class II accessory for a ventilator, and we have ideas for other devices in the pipeline. You will be responsible for letting us know how to enact these practices and for enabling our ability to perform them as easily and seamlessly as possible. This role will be at whatever capacity you have available; if you can provide us with a great deal of help, that will be very welcome, but if you can only provide advice and periodic guidance, then that will still be a huge step up from what we have now. Our current team is well versed in manufacturing, mechanical engineering, biomedical engineering, and software engineering, with document writing and product and project management. What we will need most is help making sure we can pass FDA muster. (More here: https://tinyurl.com/yym984jp )
A 4 way splitter for one ventilator so it can support 4 people at once to ease the strain on ventilators (More here: https://tinyurl.com/y4tqpza8 )If you are interested, please apply here - https://tinyurl.com/y6cyos7a - or contact email@example.com.
- A QA RA assistant for the VentOS project
Description: Help us map and track the relationship between requirements, hazards and risk mitigation using formal international quality and engineering standards so that we can produce software that complies with strict regulatory requirements for safety critical embedded software. (More here: https://tinyurl.com/y2y9g7zj )
The VentOS project aims to create a free and open-source software library and embedded operating system to enable engineering teams to develop safe and effective invasive and non-invasive ventilators for diverse contexts. (More here: https://tinyurl.com/y42gy2sj )If you are interested, please apply here - https://tinyurl.com/y54x5tgt - or contact firstname.lastname@example.org.
About Helpful Engineering
Helpful Engineering is an international, open-source community incubator focused on mobilizing people to help solve the Covid-19 pandemic and other critical issues. With thousands of volunteers worldwide, we support projects through innovations in engineering, community resources, software, and manufacturing. Most of the projects are focused on finding solutions to fix the lack of products used by healthcare professionals, including hardware and software, but also non-technical products like surgical masks.
We have engineers and doctors all around the world who are producing ventilators, protective equipment, websites, and systems to organize volunteers to assist their communities and medical workers. They are making heroic efforts to produce products in time to help the outbreak.
Check Out Helpful Engineering Here: https://www.helpfulengineering.org/
For our complete list of open positions, check out our Volunteer Opportunities: https://tinyurl.com/y6zfpc4o
Our organization is organic, transparent, and follows the principles of open source and effective altruism. Helpful Engineering expects all volunteers to adopt a professional attitude and be respectful of their fellow volunteers, which includes politeness, punctuality, giving notice, and communicating openly and transparently their work and progresses.
About Helpful Engineering
Helpful Engineering, London, London 533425, GB
Helpful Engineering is an international, open source community incubator focused on mobilizing people to help solve the Covid-19 pandemic and other critical issues. With thousands of volunteers worldwide, we support projects through innovations in engineering, community resources, software, and manufacturing.
Helpful Engineering is a 3,400 strong volunteer-run nonprofit incubator organization, with engineers, scientists, and doctors around the world dedicated to helping the world address the COVID-19 pandemic. Relying on the resourcefulness and grit of our members, we work to design innovative ways to fight the virus that causes this disease. We have partnered with medical professionals to know what would help them the most in this crisis, rapidly trying to design and arrange the production of pragmatic devices to move life-saving air, extend existing tools, or organize volunteers on the ground to bolster medical workers. The need is critical. Important but complex rules usually make these products unavailable, if unburdened, we can make them available now.