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Director of Compliance Engineering

by | Jul 8, 2020 | Careers | 0 comments

THE COMPANY

The Ventilator Project, a new non-profit startup located at MassRobotics in the Seaport district of Boston, is on a mission to construct a low-cost, universally accessible ventilator that can save the lives of Covid-19 and other patients of respiratory illnesses worldwide. Robotics entrepreneur, Tyler Mantel, founder of Watertower Robotics, wanted to directly address the biggest problems with ventilators during the Covid-19 pandemic: the cost of ventilators, which can be upwards of $40,000 apiece, and the lack of parts to build them given the bottlenecks in the supply chain for medical-grade parts. The Ventilator Project’s mission is thus to rapidly prototype, build and ship ventilators built from readily available parts at a fraction of the price.

THE ROLE

The Ventilator Project is looking for a director of compliance engineering who will be
responsible for performing administrative tasks including giving direction to the compliance
engineers, attending director meetings and keeping constant communication with each of the
directors, as well as performance evaluations on the division’s staff. This individual will be in
charge of organizing the division to ensure all action items are met on time. The director will
keep track of schedules within the department and daily check-ins with each of the analysts. This
individual should ideally have prototype or product testing experience. The compliance
engineering team will be conducting internal prototype tests, recording data, troubleshooting
prototype performance, and providing documentation for the ventilator’s performance, which
shall be delegated and monitored by the compliance director. Under the guidance of the VP, the
director of compliance engineering will ensure the prototype and manufacturing standards
comply with AAMI and ISO/IEC policies required by the FDA Emergency Use Authorization
and 510k.

Qualifications

REQUIRED SKILLS:
● Pursuing or holds a bachelor’s degree in Engineering, Management or a related field.
● Prior experience leading teams related to product and/or prototype testing in industry or
academia. FDA or any other regulatory experience is a plus.
● Robust understanding of research methodologies and statistics
● Comfortable evaluating staff performance and creating KPI’s for the team.
● 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:
● Authorship in a peer-reviewed publication, industry white paper, or industry technical
report.
● Knowledgeable of ISO/IEC regulations.
● Worked on projects involving the FDA, particularly in the medical device sector, or other
government regulatory bodies.
● Experience crafting analytical documents, memos, and draft revisions of scientific
research or policy related work.
The team comes from a diverse set of backgrounds and skill sets, but each of us share a common
calling: we couldn’t continue to sit and wait. We knew it was time to step up and find a solution.

LOCATIONBOSTON, ON-SITE

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.  

Please apply here: https://k7y.pl/s/cgtrp