David Mongin Email & Phone Number

United States

-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.

Norcross, Georgia, United States

-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.

Norcross, Ga

Norcross, Ga

Co-lead all engineering activities related to the cervical cancer product, LuViva, which has been awarded 4 patents and the 2014 Medical Design Excellence Award in the last 2 years. Collaborated with Sales and Marketing on the deployment of LuViva to over 11 countries (South America, Europe and Middle East) where I was the lead trainer of all technical staff and provided support for Sales, Clinical and Customer Service. Oversaw, the mechanical, optical and systems aspects of the product and provided support for electrical and software teams. I have also been responsible for all customer complaints, product nonconformance reports, and corrective/preventative action for the LuViva product line.While at Guided Therapeutics, I have managed the clinical datasets which include over 3000 patients scans (approximately 100 image files per patient) and demographic information. All of this data is processed and monitored via scripts in Matlab which were co-developed alongside one of the data scientist. I authored the specification documents and performed the verification/validation of the code sets once completed. In addition to my engineering roles, I also managed the IT, Model Shop and Operations Departments with responsibilities of negotiating all contracts for these departments and ensuring that all work was performed according to the regulatory requirements of ISO and FDA.

Norcross, Ga

Technical expert on the development of a next generation prototype for the diagnosis of cervical cancer. This effort delivered an instrument that could be produced in volume at 10% of the cost and less than 25% of the weight, volume and overall test time. I was also responsible for the coordination of the instruments for the clinical trials, which encompassed building the instruments, delivery and setup at the clinic, training the clinicians and overall maintenance of the instruments during the trial. This generation of the device successfully received CE Mark Approval in 2012. Technical expert on the development of a next generation laser porator for a large corporate client. I provided the oversight for the optical and mechanical designs within the team as well as coordination of the overall build and testing of the product. This redesign simplified the assembly, testing and use of the product and delivered a product that should be more reliable and free of virtually all maintenance issues of the previous generations.

Norcross, Ga

Responsible for the final engineering and construction of 5 research prototypes that were used to collect clinical data in preparation for device approval with the FDA. Additional requirements included the management of clinical data and assisting with data analysis efforts as they related to the development of the diagnostic algorithm that will be used in the devices once approved by the FDA. Co-lead the early stage research of a non-invasive, portable sensor for the continuous monitoring of alcohol as a replacement for breath analyzers or blood test. This technology employs proprietary technology, which extracts interstitial fluid from the skin via micropores, which is interrogated by an electrochemical sensor.

Modification and implementation of spectral imaging system for the detection of brain tumors and tumor margins under the direction of Dr. Anita Mahadevan-JansenDesign and implementation of a beam delivery system for neurosurgery at the Vanderbilt Free Electron Laser Center under the direction of Dr. E. Duco Jansen. Patents1. Application Number: 2012-0232404 Method and apparatus for rapid detection and diagnosis of tissue abnormalities.

Masters Of Science, Biomedical Engineering

Thesis topic: Spectral imaging for more accurate detection of brain tumors and tumor margins Advisors: Dr. Anita Mahadevan-Jansen and Dr..

Bachelor Of Engineering; Graduated, Biomedical Engineering