Rodney Flores

Design, develop, and implement packaging for ten (10) sterile medical devices and fifteen (15) instruments from all business units (Sports Medicine, ENT, Spinal) , dealing with cross functional product development teams. Coordinate set-up of new package systems test laboratory, including equipment, test method validations, and operator training. Initiative cost saving for $300,000 from previous year outsourced testing cost. Work with suppliers on existing products to optimize packaging design (blisters, pouches, folding carton, corrugated shippers), as well as processes (blister/pouch heat sealing, palletizing TOPS Software) document and validate changes under company’s quality system. Recent cost saving project consisted of changing from a die cut foam set to an injection molded EPS foam caps, with saving of 80K/year. Coordinate implementation and procurement of new packaging materials for the Costa Rica manufacturing facility. Including, writing validation protocols and other test protocols for approval of new packaging materials and designs (seal validation, transit test and aging validations) according to ASTM and ISO standards.

 Produced, prepared and test specimens used for the evaluation of sterile and none sterile medical devices package structures, according to ASTM/ISTA standards.  Design, create material specifications for product labeling, product IFUs and package graphics.  Coordinate and test current and new package materials for shelf life data.  Maintain current department standard operating procedures and engineering specifications for the packaging development group.  Interface with Product Development, Regulatory Affairs, Marketing, Strategic Sourcing and Quality Assurance in managing engineering changes, validation document, product package change field notifications and other critical documents.  Project Management and Risk Analysis.  Medical devices FDA 510K submissions experience.  Develop and coordinate obtaining new packaging materials and technologies used for gamma irradiatiated, gas plasma and ETO sterilized medical devices. Supplied by Prent Thermoforming, Relizon, Barger Packaging, UFP technologies, Tolas Health Care Packaging, Perfecseal.  Project leader on a corporate initiative to standardize package structures across all divisions.

*Start-up of Plant’s packaging manufacturing operations, including clean rooms start-up (Class 100,000 , 10,000 , 1,000 rooms). Clean rooms validations, write standard operating procedures, training of personnel, create product’s bill of material (BOM) structures and product’s device master records. *Project leader in the design, development, and installation of purified water system. Including writing validation protocol and execution. Experience in water cleaning process and equipment ( Passivation, Crest Ultrasonics, Ramco cleaning systems). *Knowledge Laser and Chemical etch marking processes. Write equipment marking programs, operator training and SOPs documentation. *Packaging equipment experience; Shankling, Belco shrink and wrap machines. Knowledge on custom made blisters sealing equipment; SCA(Alloyd), Belco, Bosch, Multivac. Including machine’s installation, start up and qualification. *Successfully transfer 20 different packaging production lines, that required the integration of a computerized label printing system. *Transferred specialized product coating process. Including equipment installations, process validation, write SOPs and training personal. *Significant experience in clean room automatic environmental control and data collection system. *“CE” product mark implementation program. Cell manufacturing programs and operator’s certification program experience.