David Mongin
Director, PMO at Werfen, Inc.
- Role
- Director, Program Management at Werfen
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About David Mongin
I have been an integral part and technical leader on the development of a cervical cancer…
Experience
Director, Program Management
Apr 2023 — Present · 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.
Education
Vanderbilt University
Masters of Science, Biomedical Engineering
1994 — 2000
Vanderbilt University
Bachelor of Engineering; Graduated, Biomedical Engineering
1994 — 1998
Skills
- Matlab
- Medical Devices
- Engineering Management
- Iso 13485
- Research and Development (R&D)
- U.s. Food and Drug Administration (Fda)
- Optics
- Image Processing
- Fda
- Quality System
- R&D
- Diagnostics
- Design Control
- Testing
- Engineering
- Product Design
- Biomedical Engineering
- Iso 14971
- Product Development
- Design for Manufacturing
- Design of Experiments
- Manufacturing
- Hardware Diagnostics
- Signal Processing
- Product Management
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