Senior Requirements Engineer

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

22 days of PTO with carryover

Company holidays and birthday off

Company-sponsored medical, dental, and vision insurance

401(k) plan

Flexible work schedule

Job summary

Universal Diagnostics S.A. is hiring a Senior Software Requirements Engineer in Dallas, TX to develop and manage software requirements for regulated IVD systems. You'll work with the Sr. Director of Software Lifecycle and Compliance, ensuring compliance with industry regulations like IEC 62304 and FDA standards.

This role demands strong skills in risk management, traceability, and cross-functional collaboration with biology, software, and quality assurance teams. Join a company dedicated to making cancer a curable disease through early detection technologies and innovative software solutions.

Qualifications

• 3+ years of experience creating and managing software requirements for Class III medical device software.
• 5+ years of experience in software requirements analysis, systems engineering, business analysis, or related healthcare software development activities.
• Experience with IEC 62304 software lifecycle processes and FDA design controls.

Responsibilities

• Develop and maintain software and system requirements for regulated IVD software.
• Ensure end-to-end traceability and support risk management activities.
• Work with software engineers and QA on compliance support.

Skills

Software requirements analysis

Risk management

Technical writing

Cross-functional collaboration

Education

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

Tools

Polarion

Jama Connect

IBM DOORS

Job description

Overview

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 read disease signals in blood 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 DNA regions associated with different cancers.

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

You will contribute as a key technical individual contributor focused on software requirements engineering, traceability, risk alignment, and verification readiness across software and automation workflows supporting early cancer detection technologies.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers and aims to have a significant societal impact by the ambitious purpose of “making cancer a curable disease by detecting it earlier.”

Responsibilities

• Requirements & Traceability Engineering — Develop, refine, review, and maintain software and system requirements for regulated IVD software, bioinformatics pipelines, computational biology platforms, laboratory automation systems, and validated software tools in alignment with IEC 62304 and FDA expectations for Class III medical devices.
• Ensure end-to-end traceability and support the maintenance of traceability matrices and design control documentation within requirements management tools.
• Ensure requirements are testable, unambiguous, compliant, and aligned with software lifecycle and validation expectations.

• Risk Management Support — Collaborate with QA and cross-functional teams to support risk management activities aligned with ISO 14971 and FDA expectations and support traceability.

• CSV & Compliance Support — Support CSV and/or CSA activities for software systems supporting laboratory, automation, bioinformatics, and quality workflows. Collaborate with QA, laboratory, and software teams to support validation documentation. Support compliance activities related to 21 CFR Part 11, electronic records, data integrity, and validated laboratory software systems. Participate in validation readiness and inspection support activities for regulated environments.

• Cross-Functional Collaboration — Work with software engineers, computational biologists, automation engineers, QA, V&V, and R&D stakeholders.

Qualifications

• Required Qualifications —
  • Bachelor’s, Master’s, or Ph.D. in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or 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 supporting risk management activities aligned with ISO 14971.
  • Experience supporting CSV and/or 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 part of our journey in this expansive time for us.