David Deleon Email & Phone Number

Morrisville, North Carolina, US

Morton, PA, US

Author, update, and manage product design lifecycle documentation, digital DHF, and DMR, including dFMECAManaged development of new electrophysiology transseptal needle from design through FDA 510k clearance within 7 monthsUpdate SOPs and design QMS sub-systems to improve compliance to Design Control and Risk Management requirementsDHF documentation.

Eagleville, PA, US

Lead engineer for several medical devices at various design stages from design concept to productionSpecialized in design for manufacturing processes utilizing 3D modelingDesigned QMS procedures for revision control and traceabilityDesigned to latest ISO and IEEE/IEC standards for medical device design and electrical safety and emissionsDeveloped.

Philadelphia, Pennsylvania, US

• Oversaw the development of a prototype Low-Shear Rate Viscometer for the testing of blood samples
• Presented concept work and project plan to potential stakeholders
• Developed detailed project schedule to meet course requirements and stakeholder needs
• Directed the efforts of 3 teammates to ensure project met aggressive R&D schedule
• Designed test sample heating chamber using Arduino microcontroller

• Performed characterization studies on current insulin pumps to assist in the development of the next-generation of insulin pumps
• Created and updated 3D models for insulin pump assembly
• Built rapid prototype tools used for pump manufacturing
• Authored instructions for the safe and efficient operation of R&D tools
• Compiled engineering prototype BOMs
• Performed worldwide study on environmental impact and legal regulation of battery disposal

Exton, PA, US

• Assisted senior product development engineers in building and testing prototype vascular closure devices
• Conducted product experiments in an in-vitro model and assisted in an in-vivo study
• Produced design history file documents such as: product requirements, design failure mode and effects analysis (DFMEA), and risk management reports
• Read and interpreted product design drawings to verify prototype assembly instructions
• Inspected prototype parts to ensure compliance to product design drawings

• Interpreted customer supplied drawings and built processes to control quality of production of cables
• Acted as the engineering support for operators to field all questions and concerns about the processes
• Communicated frequently with sales department for new orders and returns, as well as quality assurance for compliance to customer requirements
• Created qualification reports and processes to meet customer qualification standards as well as for new, unqualified products
• Managed engineering-change paperwork to correct processes

Bachelors Degree, Mechanical Engineering

Master'S Degree, Biomedical/Medical Engineering

Education record