Senior Systems Engineer

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 140,000 - 170,000; Full time

Benefits offered by this job

22 days PTO

Company holidays + birthday off

Medical, dental, vision + life, STD, &

401(k)

Flexible work schedule

Additional benefits to come

Job summary

Universal DX, Inc is seeking an experienced Senior Systems Engineer to support development of next‑generation bioinformatics and lab automation software in regulated environments. You will handle requirements, risk management, verification, and lifecycle traceability across IVD and software platforms.

You will work under the Director of Software Lifecycle and Compliance, collaborating with engineers, QA, and R&D to ensure adherence to IEC 62304, FDA design controls, and CSV/CSA expectations for

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Engineering, CS, or related technical field.
• 3+ years of experience with Class III PMA medical device software or regulated IVDs.
• 5+ years in software requirements analysis, systems engineering or healthcare software.
• Experience with IEC 62304 and FDA design controls.
• Experience with ISO 14971 risk management.
• Experience with CSV/CSA in regulated healthcare environments.
• Experience with bioinformatics pipelines or lab automation in regulated settings.
• Strong technical writing and traceability skills.

Responsibilities

• Develop and maintain software and system requirements for regulated IVD software and bioinformatics platforms.
• Ensure end-to-end traceability across life cycle.
• Lead risk management activities in accordance with ISO 14971.
• Support CSV/CSA activities and regulatory compliance.
• Collaborate cross-functionally with software engineers, QA, and R&D.
• Define interfaces and verification strategies.

Skills

Systems engineering

Regulatory compliance

Technical writing

Traceability

Cross-functional collaboration

CSV/CSA knowledge

Education

Engineering

Computer Science

Bioinformatics

Computational Biology

Biology

Tools

Polarion

Jama Connect

IBM DOORS

Job description

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 early.."

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.