values and processes abstracted; identities removed.
Additively manufactured swab microstructures addressing COVID-19 supply chain shortages and custom medical device demand.
Role & Scope: Production manager - scaled roll-to-roll-AM to 1M+ units, implemented ISO 13485/9001, improved wash and post-cure throughput 10×, and implemented Kanban production system.
#Proof
Capabilities: Achieved ISO 13485 / ISO 9001 audit-readiness • AQL Level II sampling • sterilization documentation & lot traceability
#Methods & Capability
- Standardized post-process procedures (wash, dry, post-cure, QC/QA) → 10× faster post-processing
- Implemented QMS at production scale (SOPs, travelers, document control, design transfer) for ISO 13485/9001 audit readiness
- Scaled manufacturing operations 4×, including custom AM equipment fabrication, facilities build-outs, and permitting.
- Line setup and balance: raised throughput and increased yield via Master Production Scheduling and Kanban system implementation.
- Design Transfer: SOPs + Documentation for Print, Post-process, Quality inspection, Safety, and QMS handoff.
- Integrated Quality Controls: (GR&R pre-check, FAI on recipe change, go/no-go gates) ensured repeatability and audit trail.
#Operations & QA Gates
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Parameter Window
| Parameter Window | Primary Response | Control Window | Failure Signal | First Corrective Action |
|---|---|---|---|---|
| Resin removal | UV-Vis residue | Narrow → Moderate, design-dependent window | UV-Vis signal rises | extend dwell time 1 step or 1 cycle within validated window, or by one cycle + requalify |
| Dry-down | Dimensional stability | Moderate | Distortion, yield loss | Increase dry dwell 1 step within validated window, safely below Tg + requalify |
| Post-cure energy | Tear strength | Moderate | Reduced tear strength, go/no-go gauge failure | Increase energy one step within validated window + requalify |
