Senior Systems Engineer
Role Overview
Universal DX is seeking an experienced Senior Systems Engineer to support bioinformatics, computational biology, and laboratory automation software.
The role supports compliance with IEC 62304, ISO 14971, FDA design controls, and CSV/CSA expectations for Class III medical devices and IVD systems.
This is a senior technical individual-contributor role covering systems engineering across assigned systems and workstreams.
Key Skills for This Role
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About the company
Universal DX develops multi-omics and bioinformatics models for early cancer detection and is building a multi-cancer liquid-biopsy platform.
The opportunity
Universal DX is seeking an experienced Senior Systems Engineer to support bioinformatics, computational biology, and laboratory automation software.
The role supports compliance with IEC 62304, ISO 14971, FDA design controls, and CSV/CSA expectations for Class III medical devices and IVD systems.
This is a senior technical individual-contributor role covering systems engineering across assigned systems and workstreams.
Responsibilities
- Develop, refine, review, and maintain software and system requirements for regulated systems and validated software tools.
- Ensure end-to-end traceability; support risk management, CSV, and compliance activities.
- Contribute to verification planning, test development and execution, and lifecycle traceability.
- Collaborate cross-functionally and support tools and processes.
Required qualifications
- Bachelor’s, Master’s, or Ph.D. in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or a related technical discipline.
- At least 3 years creating and managing software requirements for Class III (PMA) medical-device software or regulated IVD systems.
- At least 5 years in software requirements analysis, systems engineering, business analysis, software compliance, or related healthcare software development.
- Experience with IEC 62304, FDA design controls, ISO 14971, and CSV and/or CSA in regulated environments.
- Prior regulated-environment experience supporting bioinformatics, computational biology, laboratory automation, or validated laboratory software.
- Experience collaborating across software, computational biology, automation, QA, V&V, and R&D; strong technical writing, analytical, and traceability skills.
Preferred qualifications
- PMA submissions or FDA regulatory inspection support; IVD medical devices and CLIA laboratory environments.
- Familiarity with 21 CFR Part 11 and data integrity expectations.
- Experience with Polarion, Jama Connect, or IBM DOORS; laboratory automation, sequencing pipelines, or NGS-based diagnostics.
- Understanding of regulated software verification and validation; ability to learn new technical domains.
Benefits
- 22 days of paid time off, with up to 10 days eligible for carryover; company holidays and birthday off.
- Company-sponsored medical, dental, vision, life, short-term and long-term disability coverage, and 401(k).
- Flexible work schedule.
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