Working in a freelance capacity providing project coordination and assistance for clients using waterfall and hybrid SDLC methodologies for medical device and reagent manufacturing projects and initiatives.

While engaged as a Product Development Project Manager:• Demonstrated a comprehensive understanding of project management fundamentals including budgeting, forecasting, status reporting, regulatory and ethics and solution testing.• Guided and directed the project teams that developed the SERALYZER system for point-of-care plasma testing for 18 different analytes using dry reagent technology.• Effective with dynamic reporting relationships including direct, dual, individual contributor, contract hires, and 3rd party.• Resolute in holding strategic partners/vendors accountable for executing against priorities.• Skillful at multi-tasking, prioritizing and efficient time management. • Support the Product Owner and Development Team by organizing and facilitating the daily planning monthly steering committee meetings with sponsors and Division management and retrospective sessions.• Counseled and supported project team members and served as escalation point to assist in removing impediments and navigating organizational knowledge and resources.

While engaged as a Senior Program Manager• Lead development efforts for a disposable, wearable insulin pump working with design and software engineers to solve design problems, author QA documentation, set product specifications, and conduct V&V testing design and test results analysis. • Adept at deployment readiness tasks including documenting a comprehensive release and support plan and partnering with sponsor for change management and training planning.• Garnered trust and domain knowledge within the Human Resources, Finance, Corporate Communications and Legal business functions.• Provided design inputs to new device specifications and requirements for several start-ups. Helped determine V&V protocols, anticipated regulatory problems, and managed development steps in wide variety of projects. • Updated >3500 drug information documents to ensure consistency of text across all pharmaceutical preparations in the same drug class. Documents were written for consumer distribution by pharmacies and frequently used by nurses and doctors.

While engaged as a Product Development Project Manager:• Demonstrated a comprehensive understanding of project management fundamentals including budgeting, forecasting, status reporting, regulatory and ethics and solution testing.• Guided and directed the project teams that developed the SERALYZER system for point-of-care plasma testing for 18 different analytes using dry reagent technology.• Effective with dynamic reporting relationships including direct, dual, individual contributor, contract hires, and 3rd party.• Resolute in holding strategic partners/vendors accountable for executing against priorities.• Skillful at multi-tasking, prioritizing and efficient time management. • Support the Product Owner and Development Team by organizing and facilitating the daily planning monthly steering committee meetings with sponsors and Division management

While engaged as the Director of Diabetes Product Development at Bayer Corporation:• Lead the R&D and System Project Management teams to bring the ENCORE and ELITE glucose monitoring systems to market and to support the first years of production.• Organized quality systems development initiatives to improve testing and release methods. • Coordinated internal R&D efforts and external searches for minimally and non-invasive glucose measurement technologies. • Evaluated over 60 companies for technology acquisition.