Manufacturing Excellence in Data Collection
Developed and launched the industry's first truly paperless system, with a revolutionary implementation process.
Developed the vision, architecture, implementation, scale-up, and planning for a truly paperless data collection system for production and manufacturing environments. The solution balanced quality systems and manufacturing systems while collecting data from equipment, systems, and the human elements harmoniously. The new Mx solution drove information into a fully connected enterprise experience where data that has rarely been acted upon, is now a robust and integral part of the enterprise environment. This new data merge between systems collectively provides a new environment of reporting, management, and control of product quality and customer satisfaction. The solution was the first of its kind to put the power of implementation into the client’s hand through a patent-pending template builder and data collection builder while utilizing a patented installation and upgrade risk-based machine learning tool.
The data collection system also included a user-defined API system that was configurable to iPaaS systems, or direct to other enterprise systems such as ERP, MRP, CRM, SCM, equipment systems and others.
Electronic Data Collection Production Pilot
Developed an electronic data collection system for client order management, scheduling, production process, and more.
Designed, developed, and implemented an in-house solution for a large, international corporation to solve a communication and production information void through defining user needs, service expectations, and information gathering requirements to meet international regulations.
Implemented into a single division as a pilot test, and successfully reduce information errors, cost, and enabled analytics into the process which allowed for continual improvement projects to improve results and focus on the highest priority successfully.
Product Life-cycle Cross-platform Insights and AI
Researched, Designed, and implemented a multi-platform analytics system with integrated ML into the user experience.
Developed the researched strategy and user experience testing methods for the new cross-platform machine learning system. The system utilized correlations across the seven solutions, and API integrations to other systems, to identify and create analytics to drive executive and leadership daily decisions. The insights also provided unique user experience based on the needs of the information and placement of process within the organization. This provided a unique dashboard, as well as daily interactions for users to help improve business process management, and quality throughout the organization.
The insights planning utilized in-depth studies of users daily information use, consumption, and disbursement to pinpoint the optimum points to interject process information, and analytics to drive a lower rate of errors, non-conformances, and schedule interruptions.
Waterfall to Agile Conversion
Developed a set of teams funded by the parent company to find new ways to develop, grow, and improve the organization.
With a goal to drive innovation, new processes, and faster delivery, I was assigned as the general manager and senior product manager over a new startup division. The new division was led by me and was set out to build not only a new connected data information system but also to help define the new processes and development procedures for MasterControl’s legacy labs division. A new Lean-Agile process was implemented with immediate and direct client involvement in the build process. This led to a continual loop of client feedback and delivery, which promoted a steadily increasing velocity, a less than .001% defect rate, and high morale for the teams.
A successful beta program and reference program led to the adoption of the processes into a formal proposal and the Labs divisions successfully moved from a waterfall environment with a low level of client feedback, to a high-velocity value-driven development process.
Quality Management System Implementation
As a contract developed a quality management system for the regulated nutraceutical company Nutrix USA.
As a startup company, Nutrix USA contracted me to design and implement a low-cost quality management system to satisfy both the ISO 13485 and FDA regulations. During the implementation, a successful document management system, training system, auditing, and quality events management system were implemented.
Later, I was again contacted to assist in the upgrade to a larger and more robust system which would now include a paperless manufacturing data collection system. I helped source, design, and implement the new solution sets successfully reducing errors, production and batch release time, and enabled analytics insights into their processes.
Class III Medical Information Systems and Manufacturing Process
Led the development of the start-up division for a contract manufacturer in the Medical Device Class III environment.
Worked with the FDA, international suppliers, and manufacturing experts to develop a lean manufacturing and information handling system, to enter into the medical device implantable market for Pedicle Parts manufacturing. Sourced materials, equipment and personnel while developing an electronic data management system for adherence to the FDA CFR’s and international standards.
Drafted contractual agreements for all suppliers, third-party processing, and client quality and services agreements.
Successfully launched the initial product line on-time, under budget, and up to the client’s expectations and specifications.
Cloud Customer Relationship Management (CRM) Implementation
Sourced and implemented an upgrade to a legacy CRM system into a cloud-based retail solution.
Worked with a 125-year-old company to upgrade a legacy CRM into an on-line order-based system. Developed pricing and discount model for frequent shoppers which increased loyalty and re-order by over 500%.
Crafted an automated pricing method based on market inputs, client patterns, internal direct costs, and suppliers’ contracts.