David Heldt Email & Phone Number

East Windsor, Nj

Investigate deviation events in a manufacturing area and perform administrative tasks associated with deviation management.• Collaborate with quality and manufacturing personnel when gathering information needed to close investigations.• Familiar with the procedures of vaccine production in a GMP, GDP, class 100,000 cleanroom environment.• Complete and administrate immediate, remedial, corrective, and preventive actions associated with manufacturing investigations.• Define deviation events and assess their impact to product quality.• Analyze root cause of deviation events.• Perform data accuracy checks and second person review tasks of GMP documents in accordance with Standard Operating Procedures (SOPs).

Harleysville, Pennsylvania 19438

Developed heat seal bonds (polymer to polymer and polymer to ceramic) associated with a lithium battery technology.• Collaborated with a team of engineers and scientists to resolve product performance issues for a customer.• Communicated with team and customer to define and achieve product performance requirements related to a heat seal technology.• Developed a peel force metric to qualitatively assess heat seal performance and used the metric as a specification when eliminating alternate seal approaches to systematically determine the best solution(s).• Developed the experimental design for and conducted heat seal process optimization tests on over 40 alternate seal approaches.• Carried out quality control (QC) tests (electrolyte density, water concentration, and electrical conductivity) on electrolyte materials.• Wrote a 150 page report to summarize polymer to ceramic heat seal technology activities along with a 40 page polymer to polymer heat seal technology report.• Presented results and conclusions from heat sealing project to internal team and customer during 8 technical presentations.

Fort Washington, Pennsylvania

Performed tests on woven and non-woven textile materials in accordance with industrial, customer, and internal testing specifications.• Collaborated with research, manufacturing, and sales engineers to determine whether the company’s products could meet customer needs.• Applied technical expertise to test the mechanical, physical, thermal, chemical, and environmental characteristics of textile materials.• Wrote 15+ technical reports to share testing results with internal and external personnel.

Mclean, Virginia

Contributed to team research projects within a concrete materials laboratory.• Trained in the mixing, casting, and curing of concrete as well as its relevant ASTM testing procedures.• Conducted mechanical and thermal testing of concrete pavement specimen, which included compression, tensile, elastic modulus, poisson’s ratio, and coefficient of thermal expansion testing.• Obtained experience with federal procurement and contract procedures.• Reviewed proposals and technical reports.• Managed a tomography system and a government credit card.

Allentown, Pennsylvania

Applied understanding of x-ray tomography to meet customer needs pertaining to sample scanning services.• Trained customers in computed tomography (CT) machine and software use.• Installed and repaired CT machines.• Earned the company nearly $100,000 in both a direct (scanned samples on a paid, contractual basis) and an indirect (scanned unpaid samples that led to a customer purchasing a CT machine) manner.• Represented the company at a dental biomaterials conference and obtained 5 to 10 business contacts for review by the sales engineer.

Manassas, Virginia

Championed biomedical applications of company's powder metallurgy technology.• Utilized a design of experiments approach to optimize the processing parameters when conducting a titanium-polyurethane bonding project using a thermo-mechanical press.• Sought funding for need-based R&D projects by contacting more than 100 academic and industrial professionals.• Continued to obtain improved scores when re-submitting NIH-SBIR proposals.

Master'S Degree, Biomedical Engineering

Bachelor'S Degree, Materials Engineering