Data entry of all electronic transactions regarding consumption and/or transfer of raw materials. Pull all material(s) (FIFO/FEFO) as required by internal customers in a timely fashion. Assure compliance to all standard operating procedures. Keep both the offsite and main warehouses in an organized and orderly fashion, storing materials to preserve their integrity. Mainta

Take calls for the department Perform all housekeeping tasks. Support internal/external customers. Quality review of all Human Tissue or Medical device orders prior to shipment. Become familiar/proficient with domestic shipments. Use and navigate systems and applications used by Shipping (Lotus Notes, SAP, Microsoft, MAX (Austin) etc.) Book and route product with approved

Increase productivity and revenues by optimizing processes and work flows through experience and knowledge obtained. Initiate and provide consultation to management for cause identification and problem resolution for various types of quality investigations. Work with management to formulate and use authority to implement new operating practices to improve processes. Engag

Compliant to all SOP's, BPP's, applicable Sarbanes Oxley requirements and applicable QC/QA procedures. Manage white requisition process to include Purchase Order creation. Manage specific supplier accounts for sustaining business supply continuity to include 1) Reorder Points, 2) Delivery on time and in full, 3) Pricing, 4) Specification Changes, 5) Material/Service Non C

Maintain the domestic models or standard costing that calculate the cost of products and processed tissues and oversee international standard costing, including Prepare or review the preparation of cost models on a monthly basis Prepare or review standard costing analyses and update standard costing when needed or annually Update or oversee update to cost models periodica

Provide Design Quality Engineering support for NPD, transfer to manufacturing. Serve on the Technical Team for Aortic programs in design control. Provide Quality Engineering technical support in resolving quality issues. Create, review and approve documents required for the Design History File. Provide support to R&D to ensure design verification testing is clinically rel

Represent the entire product portfolio with internal and external stake holders, including proficiency in product knowledge, understanding of marketing strategy for each geography, key projects and initiatives and understanding of P&L. Develop robust launch plans across multiple functional areas and geographies for marketing campaign launches, showcasing project managemen

Direct the development of clinical study protocols for identified programs/products. Plan and manage all clinical trial activities including, but not limited to, site selection/evaluation, contracting, site activation, enrollment/follow up, data collection/monitoring, data analysis, site closure. Communicate with customers and technical representatives regarding the plann

Essential functions include, but are not limited to Provide Quality Engineering technical support to assist in resolving quality issues. Create and review Protocols, Process and Product Validations. Create and review documents required for the Design History File. Analyze process/product non conformances and implement comprehensive corrective and preventive action plans.

Perform Tier I Manufacturing tasks perform and review documentation of manufacturing processes in accordance with GDP Maintain individual training for all manufacturing tasks; ensure training is current Perform all tasks in accordance with applicable regulatory and industry guidelines Meets dependable performance expectations Meets communication/teamwork performance expec

Design and Development New Medical Products Utilize SolidWorks to convert concepts into detailed engineering drawings of new medical devices and subassemblies Generate prototypes using additive or subtractive manufacturing strategies Develop experimental testing strategies, protocols, and systems Define physical and mechanical testing studies to advance the understanding

Perform testing of microbiological samples including bioburden and sterility testing. Centrifuge serological specimens and separate serum/plasma. Perform environmental monitoring. Collect water samples and perform associated testing. Read cultures and perform all tasks associated with Negative Bench. Perform set up of Vitek cards and interpret test results. Perform and re

Receiving, inspection, labeling and documentation of incoming tissue. Circulate at dissection. Disinfect, assemble, and sterilize laboratory instruments. Prepare disinfectants, solutions, and intermediates. Clean processing areas and the general lab area, including laundering of laboratory scrubs and waste disposal. Monitoring and recording of equipment parameters. Supply

Receives materials and/or parts specifications from senior engineers and edits/updates technical drawings and specifications accordingly. Troubleshoots equipment and manual processes through physical inspection/diagnosing of parts. Orders replacement parts as needed. Participates as assigned in product and process improvement initiatives. Provides technical support when d

Dissect, process and document at least one tissue type. Evaluate and document attributes for acceptance per quality specifications. Perform sterile and non sterile duties for aseptic transfers. Receive, inspect, label and document incoming tissue. Circulate at dissection. Disinfect, assemble, and sterilize laboratory instruments. Prepare disinfectants, solutions, and inte