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.
- 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.
- 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