Verification Validation Engineer

• Lead and execute Verification and Validation (V&V) activities for disposable kit development.• Define test plans, methodology, test equipment, and resources to support design Verification and Validation activities.• Set-up design of experiments (DOE) andor review plan and results to support product evaluation and process development.• Establish acceptance criteria and sampling plans through statistical analysis or qualitative and quantitative testing.• Develop best practice guidelines for performing disposables kit Verification & Validation activities and champion standardization and harmonization within the R&D team.• Perform and document technical root cause investigations in collaboration with R&D hardware, software, application, manufacturing, biology, and disposable kit system matter experts (SMEs).• Support Risk Analysis activities within the R&D team and contribute to product Risk Management File (RMF).• Advise R&D team members on execution of process validation (IQOQPQ) activities and metrology best practices.• Support R&D supplier capability and quality audits.• Mitigate project technical risks, resolve issues, deliver on-time, and establish strong communications with internal and external stakeholders.• Assess product specifications and change control documentation for improving the manufacturing of new and existing devices.• Support R&D team in developing supplier quality plans, supplier specifications and defining CTQ requirements.

Created: 2025-02-24