Every business has a unique set of circumstances and needs. Two Harbors Consulting, through our combined expertise, delivers process and performance improvements tailored to these needs. Our solutions are based on industry frameworks but applied with flexibility and a genuine desire to facilitate success.
The Two Harbors Consulting Team holds over 50 years combined experience in process and performance improvement, and organizational change management and nearly 100 years of combined experience in software development and services delivery. Two Harbors Consulting staff are certified to perform appraisals and training for CMMI for Development, Services, as well as High Maturity appraisals. Our staff also include an Enterprise Data Management Expert. Additionally, our staff are certified to perform regulatory audits, engage as SAFe (Scaled Agile Framework) Program Consultants, SAFe Agilists and Certified Scrum Masters.
Becky Fitzgerald – Becky has extensive experience in healthcare corporate, consulting, and academic environments. In the ’90s Becky launched and ran the largest U.S. independent dermatopathology lab forging the first partnership with Federal Express and defining specimen handling standards. In the 2000s, Becky designed and launched the first anatomic pathology system to address automated positive patient identification for all histology, molecular, and cytology specimens, slides, and whole slide images reducing specimen swap rates to zero. Becky is a Certified CMMI Lead Appraiser, CMMI Certified Instructor and Enterprise Data Management Expert with expertise in laboratory regulations, ambulatory, hospital, laboratory, and imaging workflows, and medical device development. Becky has consulted with organizations globally in technology forecasting and adoption; workflows, value streams and operations; and business performance evolution.
Tom Klein – Tom is an expert in business transformation and process improvement and has served as a trusted advisor to business and technology leaders in several countries. Tom has held positions ranging from Product Management to Software Implementation and, for the last six years, directed process improvement engagements at McKesson Corporation. He is a CMMI Lead Appraiser for Development and Services models, a Certified Scrum Master, and a certified Scaled Agile Framework Program Consultant. He works with customers as a partner and member of the team, and seamlessly moves from working with brand-new employees to seasoned executives. His goal is to match skills, hard work, and tools to meet the needs of the customer.
Jim Shaver – An experienced hands-on leader, with over 30 years in management consulting, IT, performance improvement, and change management. Jim has a proven track record across all aspects of the software development life cycle, and is exceptionally skilled at applying a clear, analytical, and creative approach to problem solving. Jim excels in adverse or ambiguous circumstances – turning these situations into win-win solutions. Jim’s specialties include being a Certified CMMI SCAMPI High Maturity Lead Appraiser for development and services, expertise in medical device regulations (21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304) and quality systems, software measurement, project management, Six Sigma Green Belt, Agile and Scrum methods, and software development management.
George Zack – George has been in leadership and contributor roles in information technology, software development and delivery, and process improvement over the past 20 years. George is Co-founder and Principal at Two Harbors, a firm focused on helping organizations achieve greater business value and performance results above compliance and regulatory expectations. George’s recent efforts include helping medical device manufacturers connect with FDA CDRH in the Case for Quality’s Medical Device Discovery Appraisal Program (#mddap). Prior to forming Two Harbors, George led McKesson’s regulatory and quality compliance audit program which performed quality system audits for registered medical devices and pharmaceutical distribution centers in the US, Canada, and Europe. George’s experience in process and continuous improvement also includes CMMI appraisal activities, value stream mapping engagements, Agile and other SDLC transformations, Six Sigma and enterprise tool implementations. Outside of his efforts with Two Harbors, George is a volunteer assistant coach to the local high school cross country and distance running squad, and is active in various roles with his son’s Boy Scout Troop.