Software Validation Engineer

Universal Diagnostics•Dallas, TX

59d

About The Position

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.

Requirements

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

Nice To Haves

Experience with laboratory automation is strongly preferred.

Responsibilities

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