This position involves developing, modifying, applying, and maintaining standards for software systems quality operating methods, processes, and procedures. The role requires conducting evaluations of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. The successful candidate will define appropriate measures to ensure product quality and develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
General Responsibilities - Develop and implement software controls SOP within the test labs.
- Work closely with customers to understand job requirements and develop software requirements.
- Develop custom test applications in LabVIEW per customer requirements.
- Create software verification and validation plans, including the generation of test cases based on the requirements for validation.
- Verify and validate newly developed or existing test applications.
- Lead software reviews and generate software verification and validation reports.
- Manage and update the department website.
- Document all lab applications source code in Team Foundation Server (TFS) or equivalent program.
- Perform re-validation on legacy systems.
- Communicate project plans and deliverables to management and engineers on a weekly basis.
Must Have - Basic LabView programming skills.
- Certificate of LabVIEW.
- Certified LabVIEW Architect.
- Certified LabVIEW Associate Developer.
- Develop test stands.
- Strong documentation skills.
Nice to Have - 1-3 years of Medical Device industry experience.
- Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR).
- Familiarity with standards: ISO 13485, ISO 14971, IEC 60601.
- Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
- Strong written and verbal communication skills.
- Ability to work cooperatively as part of a cross-functional team.
- ISO 17025 knowledge.
Requirements - Proficient with MS Word and MS Excel.
- Expert in LabVIEW programming software with experience using NI PXI and NI test stand.
- Ability to use NI Diadem software for managing, analyzing, and reporting data collected during data acquisitions.
- Minimum of 5 years of experience using LabVIEW.
- Experience creating software test plans, test design, and test case documentation.
- Advanced knowledge of software V&V practices, techniques, and software engineering processes.
- Experience with testing in both a manual and automated environment.
- Experienced in Team Foundation Server (TFS) or equivalent programs for source code management.
- Ability to use bench-top electronic test equipment including data acquisition systems, oscilloscopes, power supplies, etc.
Physical Requirements - Mobility Requirements: Stand/Sit/Walk 8hrs/day; ability to travel across multiple campuses.
- Able to lift 25 pounds.
- Dexterity Requirements: Able to use computer & monitor to develop, review, and communicate job-related documentation.
- Hearing Requirements: Able to participate in meetings and conference calls and use telephone.
- Valid Driver's license with transportation required and ability to drive between local facilities.
Responsibilities may include the following and other duties may be assigned. The role involves ensuring that projects and process control documentation are compliant with requirements, objectives, and/or contracts. It includes reviewing software systems design, change specifications, and plans against contractual and/or process requirements. The role may involve providing or directing verification and validation of software system requirements, traceability, and testability.