Medical Device / Quality System Engineer
Company Description
At Biomeme we make things. We make hardware; we work with biological organisms; we hack smartphones. We're looking for passionate people who are skilled with their hands and have impeccable attention to detail. You should be a fast learner and not afraid of tackling challenges both big and small. No task is above or below your pay grade.

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.

Location
Center City, Philadelphia, PA 19107
Employment Type
Full Time
Experience
Mid/High Level
Job Description
Biomeme is looking for an experienced medical device engineer to guide us through the process of building an FDA-approved Class II medical device. We have been building highly-portable molecular diagnostic instrumentation & field kits and need help transitioning that into the medical/human diagnostic space. Biomeme's platform uses custom consumables and interfaces with a mobile smart device. All hardware, firmware, software, consumables, and chemistry are designed in-house. The medical device engineer would be responsible for guiding our design process through to FDA approval.

Candidates for this role:
Must have experience designing & validating medical products within an FDA-compliant quality system
Must be able to create & lead the process validation practices neccesary for FDA compliance
Must be able to generate the appropriate documents for FDA submission
Must be familiar with electronics/circuit design, firmware/software, and mechanical design
Must 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 Devices
Should be proficient in SolidWorks or other CAD software
Will 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 kitting
Accredation for internal audits, or otherwise the ability to prepare us for an audit
Experience building/designing FDA-compliant quality systems for medical devices
Experience submitting devices for EUA, 510k, CE IVDD and/or IDE clinical studies

About You
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