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Compliance Engineer

by | Jan 12, 2021 | Careers | 0 comments

All opportunities with TVP Health are currently unpaid volunteer positions that will give you a rich and unique opportunity to learn and participate alongside highly regarded industry experts.

The Company

TVP Health is a 501c3 nonprofit located at MassRobotics in the Seaport district of Boston. Our mission to simplify complex biomedical products to make them accessible and affordable for all. Our first ventilator, AIRA, was developed to be a universally accessible ventilator that could save the lives of Covid-19 patients experiencing respiratory illnesses worldwide. Current ventilators can cost upwards of $40,000. Our goal is to rapidly prototype, build & ship ventilators built from readily available parts for a fraction of this price, providing hospitals & patients with a cheaper alternative. Everyone deserves a chance to fight COVID19, fight with us. As of March 2021, our AIRA ventilator acquired the FDA EUA (Emergency Use Authorization).

DISCLOSURE: Current on-site volunteers are working in an isolated office setting while practicing safe social distancing practices. We have gloves and masks readily available, and the office space is professionally cleaned several times throughout the week.

JOB Summary

The Ventilator Project is looking for a Compliance Engineer with an engineering background who will be responsible for providing regulatory guidance to the engineering and manufacturing teams. The compliance engineer will be conducting internal prototype tests, recording data, troubleshooting prototype performance, and providing documentation for the ventilator’s performance. The compliance engineer will also work within a Quality Management System to train and ensure process quality. Under the guidance of the department’s director and VP, the compliance engineer will ensure the prototype and manufacturing standards comply with AAMI and ISO/IEC policies required by the FDA Emergency Use Authorization and 510k. 

REQUIRED SKILLS:

  • Pursuing or holding a bachelor’s degree in Engineering related fields. 
  • Prior experience in running complete independent tests in industry or academia.
  • Experience crafting analytical documents, memos, and draft revisions of scientific research or policy related work.
  • This position is on-site only. Flexibility to work part-time as well as remotely, but expected to be on-site at minimum a few times a week.

IDEAL SKILLS:

  • Knowledge of ventilatory equipment
  • Knowledge of different types and use of electrical laboratory equipment. 
  • Authorship in a peer-reviewed publication, industry white paper, or industry technical report.
  • ISO 60601 experience preferred, ISO 14971 & ISO 80601-2-80 a plus.
  • Worked on projects involving the FDA, particularly in the medical device sector, or other government regulatory bodies. 
  • MS or PhD in Engineering related fields, BME preferred. 

Please Apply Here: https://k7y.pl/s/ghRMo