Stefanie Mcfadden Email & Phone Number

Lincolnshire, IL

Responsible for the life cycle product management of Caresphere Workflow Solution software, used in the auto-verification of Hematology and Urinalysis testing as well as the lifecycle management of WAM middleware software, our legacy auto-verification system. Responsible for the lifecycle product management of the Sysmex Inventory management system, eSupply.

Medical Device consultation for Hematology Diagnostics start-up company, including: Market Research Product definition/development Regulatory Guidance Product Validation Plan

• Responsible for the overall operations of the Global Technical Support Group and all associated new product support as well as support for existing platforms and software versions. Responsible to support our hotline as.
• Provided the technical staff with basic software development quality systems training as part of an overall mentoring program to help them become more productive on their Core Teams.
• Active contributor to agile software review for current software offering using Scrum Methodology.
• Initiated cross-functional team to accurately document the support process as well as to ensure that all groups understood their specific role in the support of current customer software.
• Improved the engagement of the implementation teams outside North America by reformulating a Global Service Meeting for two-way communication of projects and issues.
• Developed department policies/procedures and communicated these at staff and service group meetings, as well as documenting these in the product service manual.

• Implemented successful service initiatives for multiple software version upgrades, including limited distribution, product education to the service organization, with on time product launch.
• Led investigations on software issues, ensuring documentation, root cause analysis and resolution.
• Conducted logistics for the next generation cloud-based platform of middleware software, including software requirements gathering/review, user interface design and service/support strategies.
• Oversaw the deployment and service education of the Quality Control Module, both initially and for each subsequent software upgrade version.
• Assessed, trained and implemented new instrument drivers for the middleware system, including those for third party instruments, working with different LIS vendors during limited distributions.
• Provided training content and presentations for customer and sales professionals in multiple markets on middleware specifics and quality control.

Columbus, OH

• Provided a variety of laboratory services to hospitals, physician office laboratories and medical device companies.
• Provided Laboratory workflow analysis and recommendations.
• Served as Physician Office Laboratory consultant and set up laboratories per CLIA Guidelines.
• Evaluated middleware software for various disciplines.
• Developed Hematology software requirements for middleware systems
• Evaluated various Hematology manufacturers new offerings, providing guidance to diagnostic companies.

• Managed the overall daily technical operations of a large clinical core laboratory composed of Chemistry, Hematology, Phlebotomy and Specimen Processing in compliance with the College of American Pathologists.
• Implemented middleware software for the Hematology instruments.
• Successful laboratory inspections by CAP, JCAHO and CLIA.
• Developed / Reviewed department policies and procedures
• Oversaw the Core Laboratory Quality Systems including CAP survey results, various QC peer review programs and turnaround time statistics.
• Evaluated new testing equipment with a cross-hospital laboratory team to ensure all points of view and concerns were addressed and equipment evaluated in a consistent unbiased manner.

Bs, Medical Technology

Business Administration