Technical Project Manager
Technical Project Manager within the Abbott Hematology PMO shepherding the development and delivery for various software and hardware projects.Products are complex clinical diagnostic devices with embedded components, optics instrument, robotics, and algorithms; and are ISO 13485-compliant, and FDA/IVDR-regulated. Project delivery articles are compliant with the Medical Device Design Control process, and include Design Inputs, Design Outputs, updates to DHF, URDs, PRDs, SRSs and many other Quality, cybersecurity, design verification, design validation, design transfer, risk management, and defect management artifacts and sub plans. As PM, I provide project leadership over multiple domains beyond software and hardware development, including Regulatory Affairs; Product Labelling; Reagents and Calibrators; Manufacturing, Suppliers, and Supplier Quality; Service and Service Training; Clinical Testing; System Verification; and Human Factors Testing compliant with Design Quality practices. I manage required Design Reviews compliant with Abbott Quality processes and industry practices. Additionally, I brief executive leadership on project status, track KPIs, schedule and budgets.Projects include:New instrument (current project)Alinity h-series v. 5.2 Software.Results Collector – Abbott Hematology’s first “hybrid” project that included two components: a Design Plan (with associated Medical Device Design Control process deliverables) and a Non-Medical Product (NMP) component which used Abbott Core Diagnostic’s internal NMP documentation processes. Managed project team of 8 cross functional subject matter experts to develop and deliver a customer-specific data aggregation tool to a research partner.Previously, worked for the team's DevSecOps group on cloud, cybersecurity, and agile transformation efforts. Managed Technical Review Board (TRB) process as TRB Chair for defect management.