Universal DX
Senior
United States · Senior
Sponsorship not specifiedDetected 48 days ago
FDA RegulatoryBioinformaticsMedical DevicesCollaboration
About the role
- In this role, you will work directly with the Sr.
- 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".
Responsibilities
- Collaborate with QA and cross-functional teams to support risk management activities aligned with ISO 14971 and FDA expectations
- Computer System Validation (CSV) & Compliance Support
- Support Computer System Validation (CSV) and/or Computer Software Assurance (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 associated with 21 CFR Part 11, electronic records, data integrity, and validated laboratory software systems
- Participate in validation readiness and inspection support activities for regulated laboratory and software environments
Requirements
- Bachelor's, Master's, or Ph.D. degree in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or a related technical discipline
Skills
- Ensure end-to-end traceability
- Ensure requirements are testable, unambiguous, compliant, and aligned with software lifecycle and validation expectations
- Support traceability
- Cross-Functional Collaboration
Company info
- Universal D X, 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 Software Requirements Engineer to join our growing team.
- 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 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.
- How you'll contribute:
- 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 supporting validated software tools in alignment with IEC 62304 and FDA expectations for Class III medical devices
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This listing is sourced directly from Universal DX's careers page and normalized into a canonical job model.