The Opportunity

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

• Collaborate with computational biology and other software teams to understand expected functional behavior of algorithms and the overall pipeline, as well as a detailed understanding of the software requirements and specifications for the software component to be tested
• Create and curate in-silico reference data sets which are representative of expected input data
• Create comprehensive, automated test strategies/plans and frameworks for verifying computational biology and bioinformatic workflows (e.g., pre-processing, pipelines, scoring modules, classifier modules)
• Create test strategies/plans and frameworks which can test containerized builds (e.g., Docker) and cloud services
• Define, write, and execute formal software test cases under
• Design Controls, in alignment with IEC 62304 and FDA guidance documents for medical device software
• Design and execute tests using automated test tools, as well as manual testing processes, for the verification of software requirements
• Assist software teams with debugging and solving issues discovered during tests
• Document formal software test outcomes under Design Controls, in alignment with IEC 62304

What you'll bring

• At least 3 years experience designing and executing software verification test cases for bioinformatics and computational biology software is required
• At least 3 years experience testing diagnostic software used for medical device products
• At least 3 years with executing formal software verification and/or validation activities under IEC 62304 and associated design controls is required
• Previous experience designing test environments and curating datasets for verifying NGS pipelines and bioinformatics algorithms is required
• Previous experience collaborating with computational biologists, bioinformaticians, R&D team members, and Q&A team members is required
• Previous experience reporting verification protocol variances and defects/issues identified during verification under design controls
• Bachelor's degree in computer science or related technical field

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