Senior Systems Engineer

About Our Company
Universal DX, 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
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 as Polarion, Jama Connect, or IBM 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.

Work arrangement
Yes