Engineering
- PRO/E design and development software
- Plastic part design analysis utilizing melt flow and FEA
- Management of plastic injection mold building, from concept through qualification
- Structured problem solving and value stream mapping from our lean/sigma trained engineers
- Continuous improvement process feeding from shop floor to leadership team
- Documented mold transfer and qualification process for existing molds
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Manufacturing
- ISO class 8 clean room with validated bio-burden control
- Assembly - mechanical, electrical and through hole PCB
- Plastic injection molding with very successful background in molding thin wall products
- Multicolor pad printing
- Manual and automated secondary operations
- Integrated ERP system with real-time machine monitoring to ensure accurate scheduling and on-time delivery
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Quality
- ISO 9001: 2008 certified
- 13485 Certified
- ITAR certified
- Environmental testing – humidity and thermal cycling
(-60° to 100° C)
- Process qualification through installation qualification, operational qualification, process qualification (IQ/OQ/PQ) format
 
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