PCBA Schematic and Layout for Component Obsolescence
CAD Work, Drawings Creation, Tooling Updates and DFM
Complaint Disposition, Supplier Quality Support, Test Execution, Non-Conformances and CAPAs
Take product from concept to launch. Generate design outpus to support submissions.
Address findings based on gap assessments to 21 CFR 820 and ISO 13485
Change control, obsolescence, COGS reduction, line transfers, post market analysis and complaint reduction
Medtronic, Boston Scientific and Hill-Rom Alumni
Engineering services in Electrical, Mechanical, Software and Quality
Experience across FDA Class I-III devices