The Opportunity:

Universal DX is seeking an experienced Software Verification and Validation Manager to join our growing team. 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 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”.

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 team

What you’ll bring:

· Strong collaboration and communication skills

· Robust experience leading and mentoring software V&V teams is required

· At least 4 years experience testing diagnostic software used for Class III medical device products and/or assays

· At least 6 years experience in Software Test Manager, Software V&V Manager, or other Software Test Lead roles

· Over 10 years experience with formal software verification and validation activities

· At least 2 years experience with next-generation sequencing (NGS) and NGS analysis datasets is required

· Previous experience designing test environments, test cases, and test automation for verifying NGS pipelines and NGS analysis algorithms is required

· Previous experience overseeing software test programs under IEC 62304, ISO 13485, and associated design controls, including traceability, is required

· Previous experience with the validation of laboratory automation workflow is required

· Previous experience with Nextflow pipeline tooling and AWS is preferred

· Bachelor’s degree in computer science, bioinformatics, or a related technical field

What we´ll offer:

We’re proud to offer exceptional corporate benefits which include:

· 22 days of PTO with the possibility to carry over 10 days to the following year.

· Company Holidays, plus your Birthday off!

· 401k retirement plan

· Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage.

· Flexible work schedule

· And more to come!