Systems Engineer

About our Company: 

Universal D****X, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers. 

The Opportunity: 

Universal DX, Inc is seeking an experienced Senior Systems Engineer to join our growing team. In this role, you will work directly with the Director of Software Lifecycle and Compliance and play a critical role in supporting the development of next-generation bioinformatics, computational biology, and laboratory automation software in compliance with IEC 62304, ISO 14971, FDA design controls, and Computer System Validation (CSV)/Computer Software Assurance (CSA) expectations for Class III (PMA) medical devices and IVD systems. 

You will contribute as a senior technical individual contributor responsible for systems engineering activities across assigned systems and workstreams, including requirements development, interface definition, risk management, verification planning, test development and execution, and lifecycle traceability. 

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: 

Systems and Requirements Engineering 

Independently develop, refine, review, and maintain software and system requirements for regulated IVD software, bioinformatics pipelines, computational biology platforms, laboratory automation systems, and supporting validated software tools in alignment with IEC 62304 and FDA expectations for Class III medical devices  

• Ensure end-to-end traceability
• Risk Management  
• Computer System Validation (CSV) & Compliance Support 
• Cross-Functional Collaboration  
• Verification & Compliance Support  
• Tools & Process Support  

What you’ll bring: 

Required Qualifications 

• Bachelor’s, Master’s, or Ph.D. degree in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or a related technical discipline