Requirements: Manufacturing Process Development | Process Validation (IQ/OQ/PQ) | PFMEA | CAPA | NCR | QMS | Risk Assessment | Manufacturing Operations | Tooling & Fixture Development | Scrap Reduction | Cost Optimization | Continuous Improvement | Medical Device Manufacturing | Supplier Validation | Root Cause Analysis. Materials R&D SME/DRI for material supplier validations: analyzed supplier data, authored protocols and coordinated test specimens, and updated material specifications.