Software Development Engineer
📋 Role Overview & Responsibilities
A leading biotechnology company focused on the detection of tumors is in need of a Software Development Engineer to help write documentation for an upcoming 510(k) or PMA. Our client is building a regulatory package for their ovarian and lung programs. This consultant will interact with the Head of Computational Biology, and the VP of Quality & Regulatory Affairs.
This is a remote role, and the assignment will likely be for 3-6 months. There is a likelihood of extension based on performance.
Requirements:BS Degree minimum and 10+ years of industry experienceMust have software engineering experience with IVDsExperience with cardiology or infectious disease IVDs preferredStrong Regulatory Software Development experienceFluent in R and/or C++Proficient with authoring necessary documentation for 510(k) or PMA.Strong understanding of inputs & outputs of software, and how it interacts with Laboratory Information Management System (LIMS)
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This position is located in United States with potential relocation and sponsorship assistance depending on candidate qualifications.
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