2019-2022

I worked in Mechanical Development designing novel test methods and validating them for the Aveir Leadless Pacemaker and JotDx Cardiac monitor.  

Became SME for Smartscope and Instron test method development. Developed and validated fixtures for standards based tests such as Environmental Conditioning (Shock, Vibration, Pressure, Temperature).  Developed in house test methods for helix fixation torque (static and dynamic) and Incision Tool Puncture Force.

Improved the incision tool included with the ConfirmRx through testing of blade puncture forces in synthetic tissue and SEM analysis of blade edges.

Qualified test equipment for the inhouse feedthrough manufacturing line.

Mechanical Engineer for the development of second source feedthrough for NGQ device.

Developed test methods at component level for Aveir feedthrough (Hipot, dimensional, lead strength)

Key Skills Developed

• Statistical Analysis of test methods (Gage R&R, t-test, etc.)

• Minitab

• Learned how a very good QMS and Quality Engineering department is run.

• Project Management of a small team.

• Environmental Testing.

• Clean Room Manufacturing.

• Biocompatibility.

• Hermetic Feedthrough Design.

• Experiment Design.

• Design Input Development, DFMEA, Design Reviews

• Trained and certified as a CAPA leader for Abbott to manage CAPA Investigations and Resolutions.

• Lead multidisciplinary teams in investigations into deficiencies elevated to the level requiring a CAPA.

• Closed CAPAs in a timely manner with monitoring plans to verify efficacy of prescribed corrective action.

• Participated in several CAPAs as SME for mechanical development and testing.

• Notable investigations include electrode damage in Aveir and blade dullness for Confirm Rx

• Developed new tests and performed testing to characterize the extent of the issues to assist in the determination of root cause and monitoring of corrective action.

Problem Statement: The electronics for BBX2 are sensitive to temperature for data resolution.  The gain and overvoltage of the silicon photomultipliers in the system vary with temperature and if not corrected for can impact image quality.

Overview: I first did rough hand calculations for the heat generation and temperature rise given cooling with ambient air. I had developed a modular mounting system that consisted of 12 SIPMs and their associated boards. Each SIPM had a complementary board with an ASIC generating roughly 1.2 W during a scan. Based on the hand calculations, the ASICSs would raise the ambient temperature in the enclosure significantly and impact the performance of the SiPMs.  I then developed a modular block detector mounting system that incorporated liquid cooling into the detector block.  The materials, sizes, and flow rates were optimized through CFD simulation in SimScale.  I then built a benchtop test to confirm the CFD calculations and compare liquid and air cooling to validate that my initial calculations were accurate.

Key Skills Developed

• CFD simulation

• Optimization based on simulation

• Test Design 

• Hand Calculations for heat generation, CFD sanity check, and risk of condensation.

After RSNA 2023, compiled feedback and iterated the design to include newly highlighted user needs.

• Added drive motor to assist with transport.

• Identified more robust lift/tilt actuator mechanism.

• Reduced overall depth to aid in maneuvering through tight hallways.

• Fleshed out documentation (Specifications, drawings, manufacturing plans, etc.)

Key Skills Developed

• Sheet Metal Design - learned new methods of designing panels and enclosures.

• User needs development from VOC discussions with potential customers.

• Electromechanical systems design and integration.

Starting in Q4 of 2022, I returned to Prescient Imaging to help develop a version 2.0 of our FDA cleared scanner.  New developments in the electronics meant we could use a much smaller enclosure.  This scanner can also lift and tilt, has a larger imaging bore and field of view and is significantly lighter weight.  I designed and built a functional prototype that we exhibited at RSNA (Radiological Society of North America) in 2023.

Key Skills Developed

• Project Management - Now leading the day to day project management tasks for all functions.

• User needs development from VOC discussions with potential customers.

• Design Inputs, Outputs, Hazard and Risk Analysis

• Manage the Quality System and Document control

2014-2017

I began my career at a medical imaging startup where we developed a novel mobile PET (Positron Emission Tomography) Scanner.  As the lead mechanical engineer I was responsible for the design of the device and the project management for mechanical development.  I had two engineers working on my team.  The BBX 1 has a 30cm imaging bore that can be raised and lowered as well as rotated to accommodate any patient position.  The BBX 1 completed and passed IEC 60601 testing in 2017.  I wrote and compiled all the mechanical specifications and hazard analyses for the FDA submission.  After clinical trials and design validation, the BBX 1 received 510(k) approval in 2020.

Key Skills Developed

• Machine Design

• Project Management and Leading a small team

• EMC/EMI Shielding - Initial prototype failed EMC/EMI due to high frequency noise. Lead design modification efforts to identify areas of leakage and fix the design.

• Requirements Development and Hazard Analysis.

• Generating drawings and specifications for vendors and manufacturers.

I was the mechanical engineer on the Pyxis Product Focus Team supporting manufacturing of the Pyxis Medstation and Anesthesia Station.  I would review and disposition nonconforming materials and track the quality metrics.  I implemented ergonomic improvements in the "drawer loading" process to reduce risk of back injuries to the operators without impacting takt time.

Received Lean Six Sigma Green Belt.

Green Belt project to improve takt time in drawer manufacturing in Tijuana plant.

Tiger Team member responsible for root cause analysis of quality issues coming from Tijuana plant.

Qualified new injection molds for plastic drawer covers as part of move to new supplier.

Gained exposure to volume manufacturing.

Key Skills Developed

• Lean Six Sigma and Design For Manufacturing/Design for Assembly certifications

• Represented mechanical engineering in several Kaizen events.

• Injection Mold Tool design and qualification.

• Root Cause analysis (Fishbone/Ishikawa diagram, 5 Whys, FMEA, Pareto charts)

• DMAIC Project Structure

2016

Built a small bore PET camera with leftover sensor electronics and a linear table.  The prototype could image a small tissue biopsy and detect the presence of radioactive FDG. The idea was to image a biopsy and identify if any radioactivity was at the margin of the sample indicating that the tumor was not fully excised.  However, image reconstruction was not of a high enough resolution for this purpose.

Key Skills Developed

• 3D Printing

• Motion control

• Programming (C#)

2006-2009

I joined the robotics team at my high school in 2006 (Chaminade Team 1138) and that really put jet fuel on my passion for engineering.  As part of the team we designed unique robots each year in 6 weeks to compete with teams across the country.  We won the Los Angeles regional in 2006 and the Chairman's Award in 2009 when I was captain.

Key Skills Developed

• Machining (Lathe, Mill, CNC programming)

• Rapid Ideation and Iteration 

• Prototyping

• Control Systems and Electromechanical Systems