Steven Haworth

WORK HISTORY

EDUCATION

SKILLS

ABOUT STEVEN HAWORTH

I am a technical software project manager in the medical software space, with years of experience in developing safe, compliant software solutions for blood analyzers and testing, hospital EMR, and insurance claim processing. I have expertise in adapting and implementing software development processes to efficiently (and sensibly) meet business and regulatory stds.In addition, I have administered Atlassian (Jira, Confluence) cloud instances since 2017.Recent work includes managing global development of cloud-based medical software applications, as well as building and administrating Atlassian cloud tools to support this work. I am the lead in adapting our Atlassian tools for compliance, risk management, testing, requirements traceability, and related needs.Past work includes managing projects to build emergency room documentation / analysis applications, insurance claims processing applications, and applications related to blood banks in both test process and donor management.My processes are Agile (for requirements, development, testing, and defect handling), but adapted to meet FDA and ISO regulations, project risk, safety risk, financial mgmt. Work includes extensive cross-functional efforts, across multiple groups and locations, focusing on business, software, and safety goals, coordinating teams, projects and budgets in Japan, Germany, Vietnam, US, and other regions. Past work includes software projects in Colorado, Canada and India. Tools included Rally, JIRA, Planview, SharePt, etc for status, budget, forecasting.Previous work includes successful FDA 510(k) submissions, quality management, auditing, SOP development, process improvement, and process optimization, and implementing or adapting Agile processes to fit business & regulatory needs.I have a strong interest in project metrics, risk management, software process, and have authored software lifecycle and risk mgmt procedures for multiple locations within Sysmex, Haemonetics, UHG / Optum, and Picis/Harris.Specialties: Regulated software development lifecycles (SDLC)Atlassian / Jira / Confluence cloud administrationAgile SDLCsProject mgmtRisk mgmtFDA 21 CFR Part 820 (QSR) regulationsISO 13485, 62304 (medical, software)ISO 14971 / IEC / TIR32 risk management stdsComplaint handlingManagement reviewInternal & external auditingCAPADocument controlMetricsProcess improvementJIRA, Confluence, Xray, Rally, PlanviewPMP - Project Mgmt ProfessionalASQ - Certified Manager of Quality / Organizational ExcellenceState of IL - Professional Engineer-in-Training (EIT)