The Opportunity

You will work directly with the Sr. Director of Software Lifecycle and Compliance and will play an integral role in contributing towards the Company's future growth by leading and ensuring that the next generation of Universal DX's bioinformatics and computational biology software is fully verified and validated.
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 teamyou 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

• Maintain and grow a software verification and validation (V&V) program aligned with IEC 62304 (ISO standard for medical device software development), ISO 13485 (ISO standard for medical device quality management), and FDA guidance documents for verification and validation of Class III (PMA) medical device software
• Manage a V&V team of Pipeline SDETs and software validation engineers who have experience with formal software V&V activities for cloud-based pipelines and pipeline deployment, in alignment with IEC 62304, ISO 13485, and FDA guidance documents for software verification and validation.
• Mentor the V&V team in best practices and strategies for NGS pipeline testing, test automation, metamorphic testing of machine learning algorithms, and validation of laboratory automation
• Design, build, test, and document formal software testing environment(s) suitable for bioinformatics pipelines, computational biology tools, and machine learning-enabled algorithms including (A) development of automated testing workflows, as appropriate, (B) creation of robust test case libraries with formal test cases, and (C) identification and documentation of curated test data sets for use during software verification and validation, aligned with IEC 62304 and FDA guidance documents for software validation and machine learning
• Collaborate closely with Production Engineering, Computational Biology, and Automation teams to understand prior testing of UDx software and tools, as well as software dependencies and deployment environments planned for Signal-C software to ensure that formal V&V test cases are designed appropriately
• Oversee the execution and completion of the overall Signal-C software verification and validation program, supporting critical partner and PMA deadlines: o Ensure that software requirements for Signal-C assay software and its software components are fully verified, including those associated with the Signal-C pipeline, scoring modules, classifier module, and its delivery platform o Ensure that software components for Signal-C assay software are fully integration- tested and validated together o Ensure that UDx lab automation workflow scripts are fully validated o Generate software verification reports and associated V&V evidence matrices o Manage Software Release Meetings and documents for successfully verified software components
• Document and assess variances associated with the execution of V&V protocols, in collaboration with the UDx QA teamWhat you'll bring

• Strong collaboration and communication skill
• Robust experience leading and mentoring software V&V teams is require
• At least 4 years experience testing diagnostic software used for Class III medical device products and/or assay
• At least 6 years experience in Software Test Manager, Software V&V Manager, or other Software Test Lead role
• Over 10 years experience with formal software verification and validation activitie
• At least 2 years experience with next-generation sequencing (NGS) and NGS analysis datasets is require
• Previous experience designing test environments, test cases, and test automation for verifying NGS pipelines and NGS analysis algorithms is require
• Previous experience overseeing software test programs under IEC 62304, ISO 13485, and associated design controls, including traceability, is require
• Previous experience with the validation of laboratory automation workflow is require
• Previous experience with Nextflow pipeline tooling and AWS is preferre
• Bachelor's degree in computer science, bioinformatics, or a related technical field

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