What are the responsibilities and job description for the Verification Validation Engineer position at TalentBurst, an Inc 5000 company?
• 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) and/or 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 (IQ/OQ/PQ) 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.
