Senior Systems Engineer - Regulated Med Device & Bioinformatics

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

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