Software Validation Engineer
Universal Diagnostics
About our Company:
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 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 is seeking an experienced Software Validation Engineer to join our team. You will work directly with the Software Verification and Validation Manager and will play an integral role contributing towards the company's future growth by leading and ensuring that all the next generation of Universal DX's automation tools and computational biology software are fully verified and validated.
How you’ll contribute:
• Collaborate with software and automation teams to understand expected functional behavior of overall assay software and automation workflows
• Create test strategies/plans and frameworks for validating software-related user needs and product requirements
• Create test strategies/plans and frameworks for validating lab automation workflow scripts
• Create test strategies/plans and frameworks for verifying software QC scripts
• Define, write, and execute formal verification and validation test cases under Design Controls
• Design and execute software verification / validation tests for lab automation
• Design and execute software validation tests for the validation of software-related user needs and associated product requirements
• Assist software and automation teams with root cause analysis and troubleshooting during validation activities
• Assist software teams with debugging and solving issues discovered during tests
• Document formal software test outcomes under Design Controls, in alignment with IEC 62304
What you’ll bring:
• At least 5 years experience designing and executing software verification and validation test cases for medical device products, biomedical software, or other regulated software products is required
• At least 3 years with executing formal software verification and/or validation activities under IEC 62304 and associated design controls is required
• Previous experience collaborating with automation engineers, computational biologists, bioinformaticians, R&D team members, and/or Q&A team members is required
• Previous experience reporting protocol variances and defects/issues identified during verification / validation under design controls
• Bachelor’s degree in computer science, engineering, laboratory sciences, or a related technical field
• Experience with laboratory automation is strongly preferred.
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 a part of our journey in this expansive time for us.
What We´ll Offer:
We’re proud to offer exceptional corporate benefits which include:
· 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
· Relocation support to the DFW area for on-site roles.
· And more to come