Adding the Systems Engineering discipline to the R&D team, interfacing with Software Development, Clinical, Quality and Marketing in the development of breakthrough implantable orthopedic medical devices.

Principal Engineer supporting the integration and development of Ichor’s TriGrid® Delivery System. The Delivery System is a technologically superior, clinically tested, integrated and automated electroporation system capable of enhanced, tolerable and reproducible nucleic acid administration in a manner capable of supporting drug commercialization. The TriGrid technology has been licensed by companies such as Pfizer and Janssen to deliver their proprietary DNA vaccines.

Nihon Kohden a world leader in integrated multi-modality products that serve patients across all care areas. Nihon Kohden specialties are neurology, patient monitoring, and cardiology, we bring clinical solutions that provide access to a deeper, more comprehensive level of information, enabling more accurate diagnoses and ultimately, better outcomes.As the Systems Engineering Lead my focus is to bridge the gap between Marketing and product development to bring about comprehensive products that provide care givers with the information that they need to make life saving decisions to patients around the world.

Responsible for the Systems Engineering Team at Nihon Kohden. The Systems Engineering Team is responsible for the System Network Design in addition to the ownership of product requirements for USLab products. Creating and implementing new product development process, simplify and clarify roles and responsibilities, review and approval and documentation requirements for our System Network Designs. The network systems installed at hospitals is a critical part of the overall performance of the Nihon Kohden monitoring solutions. Responsible for the implementation of changes to improve alignment between Operations and Engineering, to streamline the process, and to increase the accuracy of the design of the network infrastructure, network product implementations and application software products.

Principal responsibility in this position is to ensure research and development teams are in full compliance to FDA regulations and ISO standards. Reviewing the objective evidence created in the development of class 3 medical (requirements, specifications, Verification &Validation plans and reports, etc) are compliant to the regulatory standards. Participate in FDA audits, review and responding to any findings encountered by the government representatives

Responsible for analyzing customer needs, Story Boards, Use Cases and requirement development in order to produce system architecture, software design specifications and design documentation in support of hardware and software systems in Ablation technology solving Cardiac Arythmias.

Principal responsibility in this position was to ensure compliance to FDA regulations and ISO standards (full product lifecycle) for all research and development activities of released product from 1999 to 2008 for Alaris, Cardinal health and CareFusion. Performing audits of Design History Files to ensure that created artifacts (requirements, specifications, V&V, etc) generated as a result of product development processes are compliant to the regulatory standards. Participated in FDA audits, review and responding to any findings encountered by the government representative. Collaboration with direct subject matter experts within R&D, Quality and Program Management as a informational resource to ensure compliance of released product.Global Development Process (GDP) for the implementation of Design Control procedures and SOPs relating to the Quality Management System (QMS).

Coordinated the activities of a engineering core team which included Software Development, Software Quality Assurance and Marketing in the development of the next generation interface engine. The product required the complete re-design of the product as well as bringing the legacy system into Design controls for the first time. This position required training on the Medstation platform and have a working knowledge of the system and customer needs.

Performed as the key interface between Hardware and Software development, Software Quality Assurance and Marketing organizations in the creation of real-time Infusion devices, PCA, Auto-ID Module (Barcode), IV-Rite, and support software products while ensuring the satisfaction of requirements, regulatory guidelines and business processes while maintaining on-time delivery. Day to day activities included the participation in design reviews, test readiness reviews, code reviews, risk assessments, software defect issues tracking investigation/resolution and project meetings. Consistently providing the ability to be collaborative between engineering disciplines to move projects forward, creating concise testable requirements, support specifications, reducing ambiguities and releasing products that meet customer needs and expectations.Also coordinate and participate in the development of new business, proposals, budgets and addressing the resources needed development tasks..

Managed a staff of engineers in the design, development and testing of a highly configurable workflow management system (CliniVision) used in the respiratory healthcare environment ensuring compliance to regulatory requirements and ISO Standards while staying within budget and on-time delivery. Due to the changes surrounding the year 2000 software problem, management decided to evaluate the ability of the legacy system to fulfill the needs of current as well as future customers. The system was re-designed from the ground up using the latest database technology (SQL Server), User interface and notebook handheld computers with wireless communication

Lead software developer for design, integration and test of a real-time embedded software development project, creating a Remote Assets Management System (RAMS). The system was a clients/server system which processed commands to remotely control serial security video Cameras, military radios, temperature sensors and flow control devices using a host Graphical User Interface (GUI).Performed system analysis, system acceptance and coordinating integration tests of Command, Control, Communication, Computer, and Intelligence C4I Systems using Department of Defense standard 2167A. The Primary system under test was the Tactical Air Operations Center (TAOC) for both the Marine Corps and Air Force versions. Analyzed technical data obtained during the conduct of operational tests to generate test reports. Generated real-time simulation programs in order to benchmark test, ground, air and surface communication equipment.

Software V&V Engineer performing system analysis, system acceptance and integration tests of Command, Control, Communication, Computer, and Intelligence C4I Systems. Analyzed technical data obtained during the conduct of operational tests to generate test reports. Generated real-time simulation software scenarios running on an In-Plant Simulator (IPS); to benchmark test ground, air and surface communication hardware and software using appropriate government standards. Reviewed contract specifications, system specifications, schematic drawings and operator manuals to generate appropriate test plans, test procedures and reports.