Asuragen Lead Software Verification & Validation Engineer in Austin, Texas

Lead Software Verification & Validation Engineer

Date Posted



Austin, TX

Job Type

Full-Time Regular

Job Description

Participate as a member of the IT and Dx Software Development team responsible for planning, developing and executing software master test plans, project test plans, related design, automated test cases, verification and validation activities and corresponding documents that will support the various business and scientific needs of the company. Lead V&V team members to test, verify and validate programs and assure the highest degree of quality in external and internal software programs and systems using the project specific requirements and documentation as required by ISO, SDLC and Asuragen’s software development and Design Control methodology and procedures.

Ideal candidate will possess knowledge of verification and validation protocols, design of software use cases, use of story-boards; and demonstrated ability to quickly absorb and adapt to a growing and dynamic environment.

Provides leadership and direction to Software Verification and Validation Engineers and to software developers within the scope of unit test case development, execution, and related metrics.

Duties and Responsibilities Include:

  • Analyze product and sub-system requirements and develop detailed test procedures to adequately verify and validate to evaluate medical devices software and systems against the documented software requirements using the SDLC.

  • Develop detailed project plans, WBS, road map, risks, risks mitigation plans, and assumptions for the entire projects including tasks of V&V team members

  • Own the development and execution of software master test plans, user acceptance test plans, V&V protocols, designs, automated test cases, traceability metrics and related documents as called out in the project plans and SDLC

  • Either develop new or enhance existing software test suite to automate the test cases, tools and continuous test bed framework

  • Design and implement test cases in a rapid prototyping environment with minimal supervision

  • Perform and orchestrate multiple activities simultaneously

  • Work with the project team to help review and document product requirements and detailed specifications

  • Enter problems and bugs discovered into the error tracking system, verify problems are resolved, and update problem status information

  • Test software in 15+ international languages

  • Provide coaching and mentoring to Software V&V Engineers

Education and Experience:

  • BS in Computer Science/Engineering, BioTechnology or related field. MS degree preferred.

  • Minimum 5 years of experience as a project and/or team lead

  • 8+ years’ experience with hands-on software testing, regression, integration and system level test and V&V execution, plus QA experience with Windows & Linux based and QA (e.g. Renorex, Selenium, Mercury Tools and other testing tools) technologies

  • Hands-on with test plans for white/black box testing, create test plans and test cases

  • Exposure to many different products, software quality assurance methodologies, data virtualization and computer environments

  • Understanding of RDBMS fundamentals and working knowledge of SQL and any database experience

  • Familiar with various operating systems and networking (Windows, Unix/Linux) protocols

  • Experience with one of the following - Crystal Reports, MS SQL, MySQL Reporting

  • Must have successfully completed COTS package testing, verification and validation experience in a .NET project with C#, MS SQL, MS Visual Studio, Python, Postgres DB, Java Script, and in Linux as development environment

Skills and Competencies:

  • Work collaboratively in a cross functional team project environment ( including research, Bioinformatics, QA, regulatory, commercial, project management)

  • Specify, plan, and code functioning software to solve existing user problems

  • Ability to understand and maintain code written by other people

  • Ability to maintain flexibility with respect to project work and environment, delivering with time and budget parameters

  • Develop detailed project plans, WBS, road map, risks, risks mitigation plans, and assumptions for the entire projects including tasks of V&V team members

  • Ability to work independently and report project status to management as required

  • Ability to communicate clearly with wide range of individuals at various levels

  • Creative problem solving

  • Excellent verbal and written communication skills

  • Independently lead and manage tasks/modules across multiple projects