With over 40 years of product development and quality management work in the medical device industry I specialize in simplifying your company's product qualification and remediation work. I have spent years working with Senior Management to provide the most effective development strategies that align with their long-range plans.With such diverse experiences as configuring Product Life-cycle Management systems, redesigning quality management systems, and remediating design verification… Show more With over 40 years of product development and quality management work in the medical device industry I specialize in simplifying your company's product qualification and remediation work. I have spent years working with Senior Management to provide the most effective development strategies that align with their long-range plans.With such diverse experiences as configuring Product Life-cycle Management systems, redesigning quality management systems, and remediating design verification processes, I can help simplify your product portfolio while assuring compliance to FDA and EU regulations. Show less

Manufacturing, Operations and Quality ConsultingJPS CONSULTING LLC, Galena, IL. 61036Consulting to manufacturing organizations in the area of Manufacturing, Operations, and Quality Systems. Working with a major supplier of blood management products and services in the following capacity:• Division Quality Management Representative and Quality Partner to General Manager• Resolution of a 2 year old FDA warning letter and remediation of Division Quality Management… Show more Manufacturing, Operations and Quality ConsultingJPS CONSULTING LLC, Galena, IL. 61036Consulting to manufacturing organizations in the area of Manufacturing, Operations, and Quality Systems. Working with a major supplier of blood management products and services in the following capacity:• Division Quality Management Representative and Quality Partner to General Manager• Resolution of a 2 year old FDA warning letter and remediation of Division Quality Management System• Subject Matter Expert in remediation of Design History Files for products at division and corporate level• FDA audit preparation for division and corporate organizations• Remediation of design and quality systems including the design history records for design input, output, verification, validation and design reviews. • Key input on design changes and the affect changes have on the key design inputs for criticality of the overall design.• Remediation effort at division and corporate wide for complaint management.• Aided in the evaluation of statistical analysis and processes used to evaluate product functionality Show less

ICU Medical, acquired Hospira, Inc. from Pfizer in 2017. Hospira was the world's leading provider of injectable drugs and infusion technologies. With the acquisition of Hospira Infusion Systems from Pfizer, ICU Medical became the only company to focus exclusively on IV therapy across the continuum of care.Through its broad, integrated portfolio, ICU Medical was uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.The Vice… Show more ICU Medical, acquired Hospira, Inc. from Pfizer in 2017. Hospira was the world's leading provider of injectable drugs and infusion technologies. With the acquisition of Hospira Infusion Systems from Pfizer, ICU Medical became the only company to focus exclusively on IV therapy across the continuum of care.Through its broad, integrated portfolio, ICU Medical was uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.The Vice President Quality, Device Engineering is responsible for the development and execution of Quality strategy related to the design space of devices in support of both emerging and existing product portfolios. The vice president will assemble, develop and direct a staff of leaders who possess technical expertise and leadership skills necessary to achieve best in class quality performance.As Champion of the Compliance Master Plan, responsible for the redesign of the device quality management system to assure a fully integrated system compliant to ISO13485 and 21CFR820. This project was accomplished on-time and under-budget and in less than 18 months. Since going live with this system, Hospira has successfully transitioned to a new notified body and experienced a number of FDA investigations testing its quality management system. Show less

Teaching New Product Development (ISYE 453/553, Integrated Product Development)

AlixPartners is a global firm of senior business and consulting professionals that specializes in improving corporate financial and operational performance, executing corporate turnarounds and providing litigation consulting and forensic accounting services when it really matters – in urgent, high-impact situations.Worked on an Enterprise Improvement project at a major Aviation MRO organization. – Helping the organization understand their operational inefficiencies and… Show more AlixPartners is a global firm of senior business and consulting professionals that specializes in improving corporate financial and operational performance, executing corporate turnarounds and providing litigation consulting and forensic accounting services when it really matters – in urgent, high-impact situations.Worked on an Enterprise Improvement project at a major Aviation MRO organization. – Helping the organization understand their operational inefficiencies and operations planning opportunitiesWorking with a major supplier of medical devices specializing in implanted tissue used for medical reconstruction.– Helping the organization optimize their quality and operations processes.Working with a major General Aviation aircraft manufacturer.– Helping them establish an AS 9100 Quality Management System to grow their manufacturing capabilities. Show less

$12.5B healthcare manufacturing firm and leader providing critical therapies for life-threatening conditions. Company manufactures and markets products and services used to treat patients with hemophilia, immune deficiencies, infectious diseases, cancer, kidney disease, trauma and other disorders.• Managed overall deployment of quality systems and the Product Development Procedure (design controls) in device design centers – globally.• Responsible for Reliability Engineering… Show more $12.5B healthcare manufacturing firm and leader providing critical therapies for life-threatening conditions. Company manufactures and markets products and services used to treat patients with hemophilia, immune deficiencies, infectious diseases, cancer, kidney disease, trauma and other disorders.• Managed overall deployment of quality systems and the Product Development Procedure (design controls) in device design centers – globally.• Responsible for Reliability Engineering operations in Device Design Centers• Led Business Excellence organization and Lean Six Sigma initiative. Show less

• Responsible for the Corporate Quality System, Quality IT Systems, Data and Document Management, Reliability Engineering, and Business Excellence.• Redesigned and led global deployment of Corporate Quality System including quality system IT solutions for Corrective and Preventive Action (CAPA), Complaint Management and Product Lifecycle Management.• Led redesign of Product Development Process in compliance with FDA Guidance for Design of Medical Devices.• Quality Management… Show more • Responsible for the Corporate Quality System, Quality IT Systems, Data and Document Management, Reliability Engineering, and Business Excellence.• Redesigned and led global deployment of Corporate Quality System including quality system IT solutions for Corrective and Preventive Action (CAPA), Complaint Management and Product Lifecycle Management.• Led redesign of Product Development Process in compliance with FDA Guidance for Design of Medical Devices.• Quality Management Representative for Device Design Center of Excellence• Quality Management Representative for Global IT organization Show less

Managed and developed business consulting practice as Cincinnati Practice Leader for Cincinnati, Dayton, Louisville, Lexington and Northern Kentucky.Partner in Arthur Andersen Integrated Supply Chain practice and Director of the Manufacturing Execution and Excellence area within that practice.Typical clients included:• Division of Fortune 100 medical implant manufacturer – Lean / JIT Manufacturing.• World leader in consumer products – Product Line IT Strategy.• $4B… Show more Managed and developed business consulting practice as Cincinnati Practice Leader for Cincinnati, Dayton, Louisville, Lexington and Northern Kentucky.Partner in Arthur Andersen Integrated Supply Chain practice and Director of the Manufacturing Execution and Excellence area within that practice.Typical clients included:• Division of Fortune 100 medical implant manufacturer – Lean / JIT Manufacturing.• World leader in consumer products – Product Line IT Strategy.• $4B automotive supplier – Supply Chain / Logistics and Manufacturing Systems.• World leader in armored vehicle production – Manufacturing Systems redesign. Show less

Total Quality Management consulting firm specializing in work with Fortune 100 companies.

Sixty percent market share leader for North America in production of small bore pneumatic and hydraulic actuators.Executive responsibility for Engineering, Research and Development, Quality Assurance, and the Pilot Plant manufacturing division. Chief Technical Officer, Corporate Quality Officer.

Major supplier of large bore (1 1/2" – 24") hydraulic and pneumatic actuators to all branches of industry. Executive staff level responsibility for all engineering design and quality functions.

Custom nuclear engineering and fabrication company that designed nuclear containment structures and fabricated containment personnel penetrations and special doors.