Engineering Device Performance Analysis

Product Development Medical Instruments:- Identify, assess, and obtain available technology for product line expansion, and support Legal/IP resolution. Perform literature searches and review reference material related to device safety.-Interpret and review of scientific and engineering data to determine validity, significance and applicability to medical device design and patient safety. - Create new product evaluation protocols. - Oversee clinical evaluation and troubleshooting of new products by identifying and collaborating with outside resources such as testing laboratories, consultants, and clinical evaluators. - Analyze data, write reports, and respond to questions for FDA 510(k) submissions on new products. - Modify existing protocols for application to specific devices. - Support the management of international expansion (e.g. Health Canada, Latin America).-Project Leader for the development and market introduction of product launch. -Create market requirements for the device by conducting a comprehensive evaluation of competitive products, as well as interacting with prospective customers and field sales personnel.-Monitor contract laboratory and clinical site evaluations.-Draft data section of the FDA 510(k) submission.-Created comprehensive sales collateral package, including sell sheets, competitive product analysis, software tools to support market introduction.-Work with Contract Sales to present the products appropriately in GPO and U.S. Government contracts.-Train the Field Engineeriing, Clinical Nursing and Sales force.-Develop and coordinate displays of the disinfector and accessories at major meetings. -Develop and manage the processes for the presentation of technical, clinical and marketing materials to healthcare professionals, including professional organizations, customers, GPOs/IDN, VA, and related parties. -Expand the market for products by increasing claims, establishing new applications and new sales channels.

Product Manager -Responsible for P&L, business development vendor selection, contract development and business terms with vendors. -Day-to-day management of Cleaning, Disinfection and Sterilization product lines and other accessories.-Manage sales and internal support resources such as technical and regulatory support.-Select and rollout new products. -Promote and market products to the sales force and customer base. -Manage and develop product promotion and business development strategy and tasks.

Product Engineer -Take engineering design specifications and technically translate to the Field, Engineers/ Sales.-Provide technical feedback to R&D, Regulatory Affairs, and Marketing for Product Development -Troubleshoot and solve technical problems in the field, evaluate and support prototype products. -Develop training materials for Field Engineers, Sales Force and Support Personnel-Develop competitive comparison materials to support sales