Marcel Pena Email & Phone Number

United States

Intravitreal Injection DevicesAncillary Devices for Intravitreal Injection [i.e., From General to Specific Intended Use]Large Volume On-body Injectors

Deerfield Beach, Florida, United States

Gaithersburg, Maryland, United States

King Of Prussia, Pennsylvania, United States

• Technical lead for the drive subassembly within 1 mL single use on body injector combination product.• Challenged the existing drive system technology developing a split-ring self-locking planetary gear drive system, which later progressed to a comprehensive DFSS and Pugh Matrix exercise• Conceptualized and developed several end-of-dose detection mechanisms, capable of minimizing dead volume to 50µL worst-case • Integrated necessary functional modifications learned from previous design iterations and DFM/DFA feedback from vendors into the next device iteration to enable high-volume manufacturing processes• Technical support for the creation of design controls deliverables to comply with combination device regulations under 21 CFR 820 and ISO14791• Aided the company in design freeze and technology transfer activities to highest quality and most cost-efficient long-term manufacturers

King Of Prussia, Pennsylvania Area

• Designed, prototyped, and tested a mechanical drive sub-assembly capable of delivering 1 mL of drug under 45 s within a single use on body injector combination product• Developed electromechanical fixtures to support testing and 2 feasibility builds involving 700 prototypes• Developed and empirically tested a fluid dynamics MATLAB model to estimate drug delivery time• Ran nonlinear static FEA study on plastic gears to estimate deformation over 3 years shelf-life• Developed a water evaporation characterization study within a test chamber to support a 3-day microliter basal delivery from an insulin pump• Gained strong hands on technical skills performing failure investigation on electromechanical sub-assemblies typically comprising of micro-molded interacting components, optical and hall-effect sensors

Miami/Fort Lauderdale Area

• Defined design requirements for an upper-torso simulator featuring critical care interventions• Reverse-engineered clayed organic forms to generate low-pressure plastic injection molds• Optimized existing low-pressure plastic injection molds used for commercial manufacturing• Researched and tested multiple elastomer mix ratios for skin simulation

The Wallace H. Coulter Department Of Biomedical Engineering Design Lab

Evaluated, diagnosed, and repaired 10 MakerBot 3D printers with no technical support.Identified the problematic areas and established best practices for training and use.

Master'S Degree, Materials Science, 3.94

Bachelor'S Degree, Biomedical/Medical Engineering, Highest Honors

Associate'S Degree, Computer Engineering, 4.0

Associate'S Degree, Computer Science