Engineering Development And Transfer To Manufacturing
Client : Bio-Analytical instrument company
Project duration : 16 months
The client developed internally a powerful analytical laser based fluorescent system to detect small Biomolecules using a propriety immuno-chemistry method. This consultant was retained to assist in product engineering, building pre-production units for internal validation, and to engineer the final product for transfer to manufacturing.
This consultant developed the Product Requirement Document (PRD) selected and contracted with two development teams. This consultant planned the project and its deliverables and supervised over a $1 Million budget for 9 months to design and build the production units. This consultant managed the development of units to requirements, within schedule and budget and subsequently for 12 pilot production units.
This consultant performed the planning and selection process to identify and retain a quality Contract Manufacturer (CM). The product was transferred and validated at the CM. This work was done under the ISO 9001 and 13485 quality system guidelines.
Figure 1 - Original Internal Prototype Instrument
Figure 2 - Final Released Instrument Product
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