Universal Diagnostics S.L. (UDX) is a Spanish in-vitro diagnostics company developing a platform of minimally-invasive, blood-based solutions for detecting cancer early when treatment options are more plentiful and survival rates are still high. Backed by MedTech Innovator.
About the role
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...
What they're looking for
- Ensure end-to-end traceability
- Risk Management
- Computer System Validation (CSV) & Compliance Support
- Cross-Functional Collaboration
- Verification & Compliance Support
- Tools & Process Support
More about this role
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.
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...
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