Biomeme is as interdisciplinary as it gets. We combine rigorous biology and chemistry with best-in-class hardware and software engineering. It's all wrapped up in sublime user design, with the goal of helping our customers enact real-world change. Guided by data and a belief in the iterative process, we develop elegant solutions to complex problems that demand precision.
Our partners and customers span a wide range of industries across the US, Latin America, Africa and Europe. We've got great traction in health: we're testing for STD's in Philadelphia, Malaria and Ebola virus in Africa, Avian Influenza in Europe, veterinary targets in the Andes and Lyme disease in the US. Outside of health, we have partners in industrial water monitoring, aquaculture, agriculture, conservation biology and more. High school students are testing for mislabeled sushi. Quantified Selfers are tracking their microbiome. Everyday users are even testing their own DNA for genetic markers.
We also recently began work on a multi-year, multi-million-dollar contract with the US Government. It's a good time to come onboard.
Candidates for this role:Must have experience designing & validating medical products within an FDA-compliant quality systemMust be able to create & lead the process validation practices neccesary for FDA complianceMust be able to generate the appropriate documents for FDA submissionMust be familiar with electronics/circuit design, firmware/software, and mechanical designMust be familiar with ISO 13485, ISO 14971, Quality Management Systems, Design History Files, Design Reviews, Design Controls, Management Review Meetings, Risk Analysis/FMEA, Complaint/Adverse Event handling practices, Process Validation, Supplier Management, and all other aspects of an FDA 21 CRF 820.30-compliant QMS for Medical DevicesShould be proficient in SolidWorks or other CAD softwareWill expand + work within our existing cloud-based QMS
The following are preferred, but not neccesary:Design For Manufacturing (DFM) experience for electro-mechanical products and/or disposables or diagnostic kittingAccredation for internal audits, or otherwise the ability to prepare us for an auditExperience building/designing FDA-compliant quality systems for medical devicesExperience submitting devices for EUA, 510k, CE IVDD and/or IDE clinical studies
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