• Dark Horse Consulting provides services to support clients in the cell and gene therapy industry including project management, manufacturing evaluation, and product development services.• Process development functions include supplier auditing, contract manufacturer selection, and risk assessment.• Engineering functions include development of instrumentation/devices, vendor selection, process improvements, manufacturing planning, risk analysis, and quality systems documentation.• Regulatory support functions include regulatory strategy, submission authorship, and protocol/report execution.

• Led 8 projects from 7 different companies as the lead engineer and project manager.• Authored User Requirements Specifications (URS), generated project estimates, managed timeline/milestones, and maintained time/material costs for each project.• Designed various medical devices and instruments for customers:- Medical diagnostic and sample collection products for high-volume manufacturing.- Microfluidic cartridges for mixing, transport, separation, and metering of fluid volumes.- Prototype instrumentation for microfluidic cartridges, using mechanical/pneumatic actuation and workflows programmed using a PLC.

• Developed long-term implantable medical devices and surgical tools from initial concept to use in a clinical trial.• Led the design and development of a combination product manufacturing system (cell loading, packaging, surgical tool interface) to support a Phase 1 clinical study.• Early stage development responsibilities included design (product prototypes and test systems), researching new potential technologies, conducting feasibility studies, developing manufacturing processes, establishing test methods, and identifying vendors.• Manufacturing and process engineering responsibilities included design (fixtures, tooling, and equipment), writing manufacturing documentation (specifications, engineering drawings, SOPs, IOQs, and Batch Records), instituting process/design improvements, developing quality control inspections, writing URS, and sourcing equipment (custom and off-the-shelf).• Design control responsibilities included writing design requirements, product specifications, project plans, and risk analysis documents.• Authored regulatory submission sections of a FDA Investigative New Drug (IND) application and Medical Device Master File (MAF).• Authored and executed verification/validation activities including simulated use, fatigue, biocompatibility, shipping, and environmental testing.• Established Solidworks PDM system in compliance with FDA requirements and acted as administrator.

• Wrote and implemented IQ/OQ/PQs of new fixtures, tooling, automation, and manufacturing processes for the manufacture of medical instruments.• Ensured compliance of products thru Manufacturing Instruction updates, tooling requests, time studies, customer return investigations, and corrective actions for rejected materials made by vendors/in-house.

• Designed and machined parts for a prototype for a new laboratory instrument which utilized motors, valves, and a heat transfer block.• Performed preliminary research and development through prototyping and experiments for an automated laboratory process which utilized microfluidics.• Tested and optimized a laser marker/cutter using statistical analysis.

• Designed a experimental test method to capture and analyze fluid flow for a medical device with a high-speed camera, custom test fixture, and ProAnalyst video tracking software which resulted in a test that enabled faster design iteration.• Conducted statistical analysis of results from experimental method in order to ensure that values were consistent with fluid theory and to determine if the medical device could be optimized for performance.

• Advised students on senior research projects on topics of car suspension optimization, wing aerodynamics, airflow through vents, fusion theory, and heat transfer through brake discs.

• Guided students on a wind tunnel experiment aimed at teaching the fundamentals of aerodynamics and airfoil theory.• Assisted in teaching students to acquire the technical writing skills necessary to develop a clearly written, coherent laboratory research report.

• Utilized COSMOSFloWorks CFD to optimize a filter flow model design prior to prototyping.• Designed a product prototype which utilized a system of microfluidic channels and devices to conduct complex laboratory experiments.• Increased efficiency, speed, and accuracy in a laser marker/cutter and an ultrasonic welder production process tools through statistical analysis with Minitab.• Developed and built a prototype locking mechanism for use in a laboratory instrument.• Designed a quality control method and test fixture for lab-use devices to ensure proper performance.• Wrote a design of experiments (DOE) to optimize dimensions and timing for a microfluidic pump device in order to increase throughput in a new product prototype.

• Designed a chamber for testing of response time of detecting certain chemical gases.• Utilized fluid mechanics to design/machine a prototype airflow system for a handheld device platform.• Acknowledged contributor in publication titled "Ultra-low drift in organic thin-film transistor chemical sensors by pulsed gating", J. of App. Phys. 102.

• Investigated and recommended potential designs and hardware for a new incubator platform by utilizing theoretical calculations and experimental testing. • Wrote a design of experiments with Stat-Ease to determine ideal parameters and settings to increase reliability and cost-effectiveness of test devices. • Performed detailed FMEA analysis and device optimization of machine components.

• Conducted weekly sessions to introduce and teach the fundamentals of engineering graphics and design through machining skills, AutoCAD/Inventor, report writing, and teamwork.• Assisted students in applying engineering tools to design and fabricate robots for a competition.

• Tested and compared various sensor components utilized in the device with Labview software and performed data analysis to characterize flow within the device.• Created a leak and occlusion test method for in-process manufacturing testing of medical devices.

• Developed a manufacturing method and fixture for a heart support device.• Performed analysis to automate equipment for a Six Sigma project which led to time/cost savings.

• Redesigned existing manufacturing equipment which required fast transport, low temperature, and ease of use to increase yield and reduce product loss during manufacturing process of a human dermal substitute.

• Performed seismic/safety tests and calculations for semiconductor handlers and recommended machine modifications to meet multiple international standards. • Designed a handler modification using Solidworks to adapt to a client’s needs. • Analyzed and developed a solution for a lighting and camera system.

• Formulated reports on influence of political contributions by Tobacco Companies on state/local laws.• Researched legislation for members of Congress regarding campaign finance reform.