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.
Conference Track: Improving Capability in the Medical Device Industry
The FDA’s collaborative pilot program intends to simplify regulatory requirements for medical device makers who are committed to quality manufacturing practices. The pilot program leverages CMMI V2.0 to assess medical device manufacturers against industry best practices and offer improvement opportunities. Find out more about the tailored application of CMMI V2.0 and what it takes to get involved.