Project Manager

FUJIFILM Medical Systems U.S.A., Inc.   Morrisville, NC   Full-time     Engineering
Posted on July 11, 2021

FUJIFILM Medical Systems U.S.A., Inc. in Morrisville, NC seeks Project Manager to serve as a key member of the FMSU Project Management team, responsible for managing projects for the information and medical imaging software suite. Reqs: Master’s or equiv in Eng (any), CS, Comp Eng, Comp Apps, Info Systs, or reltd & 2 yrs of work exp in position offered or reltd or Bach or equiv in Eng (any), CSci, Comp Eng, Comp Appl, Info Syst, or reltd & 5 yrs of work exp in position offered or reltd, incl 1 yr of exp w/: mngmt of new generation healthcare imaging apps, incl image processing algorithms incl image reconstruction & 3D volume rendering, image data processing incl high speed image data acquisition/retrieval for PACS implementations, & image measurements incl cardiac flow measurements; projects devd using healthcare standards (DICOM, HL7, IHE, HIPPA), complying w/ indus standard quality processes (ISO 13485:2003, FDA’s GMPs, IEC 62304, ISO 14971) w/ Global Teams in US, Japan & India; quality Standards & Regulations for medical devices & how they apply to SW: ISO 13485:2003, FDA’s GMPs, IEC 62304, ISO 14971, & creating, maintaining & implementing ISO/GMP compliant Product Devt Process for SW Medical Devices; interacting w/ internal & external ISO & FDA auditors to facilitate successful audits; working w/ Agile & traditional SW eng proj mngmt practices & methodologies, incl adapting Agile practices to the devt of SW in ISO/GMP regulated environments, & utilizing non-Agile (waterfall) SW eng methodologies; req Mngmt tool; Microsoft TFS, JIRA, MS Project, & SW validation & Verification Planning & Execution exp on web & desktop based healthcare PACS/CV/RIS apps using .Net w/ Oracle, IIS, HTML, Java script, XML, Coded UI, Automation, Visual Studio, TFS\Microsoft Test Manager, REST. Resume to FUJIFILM Medical Systems U.S.A., Inc. to & ref title in subject.