Senior Systems Engineer

Aboutour Company: 

Universal DX, Inc. is an internationalCompany with ahighly experienced team focused on cracking cancer’s code. Through our multi-omics andbioinformaticsmodels, we have figured out how to read the disease’s signals inbloodwith high accuracyto detectcancer in its earliest stages. Starting withacolorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that canidentify the unique DNA regions associated withdifferent 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 andRequirements 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  

• 3+ years of experience creating and managing software requirements for Class III (PMA) medical device software or regulated IVD systems  

• 5+ years of experience in software requirements analysis, systems engineering, business analysis, software compliance, or related healthcare software development activities  

• Experience with IEC 62304 software lifecycle processes and FDA design controls for medical device software  

• Experience creating and managing risk management activities aligned with ISO 14971  

• Experience supporting Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities in regulated healthcare, laboratory, or medical device environments  

• Prior experience supporting bioinformatics pipelines, computational biology software, laboratory automation workflows, or validated laboratory software systems in a regulated environment  

• Experience collaborating cross-functionally with software engineers, computational biologists, automation engineers, QA, V&V, and R&D stakeholders  

• Strong technical writing, analytical, and traceability management skills  

Preferred Qualifications 

• Prior experience supporting PMA submissions or FDA regulatory inspections  

• Experience with In Vitro Diagnostic (IVD) medical devices and CLIA laboratory environments  

• Familiarity with 21 CFR Part 11 and data integrity expectations for validated software systems  

• Experience with requirements management and traceability tools such asPolarion,Jama Connect, orIBM DOORS  

• Familiarity with laboratory automation workflows, sequencing pipelines, or NGS-based diagnostic systems  

• Understanding of software verification and validation methodologies in regulated environments  

• Ability to rapidly learn and support new technical domains and software functionality  

What we´ll offer: 

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

• Company Holidays, plus your Birthday off!   

• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).  

• Flexible work schedule   

• And more to come!  

 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.