JAMES FREITAS Engineering Consulting, LLC

Independent Contractor providing Engineering and Operations support.

JAMES FREITAS Engineering Consulting, LLC
PRINCIPAL ENGINEERING PROFESSIONAL

 Biotech & Medical Device Proficiency
 Regulatory Compliance and Audit Inspection Readiness
 Startup Experience
 Product Development, Process Development, Supplier Development, Manufacturing NPI Transfer
 Industrial & Manufacturing Engineering Expertise
 Validation Services (PV, MVP, TMV, CV, Software, Packaging/Transit, Sterilization, etc.)
 Clean Room (CER) Construction, Layout, Setup, Validation and Commissioning
 Implant Expertise – Class III/II Implant/Component Development & Testing Management
 Design Transfer, V&V Testing, Risk Assessments, DFM, DFA, DFT
 Operational and Manufacturing Setup and Support
 Standard Cost Determination, BOM Cost/Financial Models, Cost Reduction
 Stabilizing, Streamlining & Ramping Manufacturing
 Quality Engineering Services

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