David Mongin

Director, Program Management @Werfen

US

Responsible for initiating, defining, planning, scheduling, and budgeting of assigned Product Development Process and Change Control programs-Communicate project status, risk, revenue forecasting and changes to internal and external stakeholders. Advocate for project internally to Immucor management and functional groups-Develop relationships with internal resources (Research and Development, Regulatory Affairs, Analytical QC, Quality Assurance, Manufacturing, IT, Finance, Legal, and Senior Management), to ensure success of the program-Lead the project team through influence and relationship development -Responsible for ensuring the project as executed adheres to the Product Development Process and Quality systems-Drive development of agreements and contract terms with external vendors needed to advance projects to signing of a license and/or supply agreement-Monitor opportunities for and drives publishing of project results-Provide monthly and annual forecasts of current projects for both burn rate and resource utilization to aid Finance and Senior Management in corporate financial goals and estimating operating budgets-Responsible for demonstrating an understanding of the key US and ex-US medical device regulations affecting the business and assure compliance with those regulations.

Vanderbilt University

Masters of Science, Biomedical Engineering

Vanderbilt University

Bachelor of Engineering; Graduated, Biomedical Engineering