Mechanical Engineer Medical Device

Mina Leung

Objective

Seeking a Principal Mechanical Engineer position

Summary

Hands on Mechanical Engineer specializing in innovative product design, with an emphasis on medical device design, enclosure design as well as mechanism driven design. Currently holds 7 patents, and 6 patent applications. Proven track record playing pivotal roles in successful programs and solving tough technical problems. My specialties are SolidWorks CAD, surfacing, mastermodel-ing, injection molding, sheet metal stamping, 4th-axis CNC machining, lathe, 3D printing, laser cutting, laser welding, extrusions, testing, tolerance analysis. Additional skills include project-managing, mechatronics, C, C++ programming, Arduino programming, GD&T, FEA, industrial design, and user-experience work. Experience

Tesla Motors Palo Alto, CA

Staff Mechanical Design Engineer Sept. 2023-June 2024

• Project managed and co-lead with one other, solved battery module assembly yield issue that was putting customer safety at risk. Designed innovative drop-in solutions taking into account potential operator error. Built single cell cycle tester to confirm root cause hypothesis and to test design solutions. End result: production line in process of revamping station based on team learnings.

• Managed and lead project trialing novel method of introducing a conductive path to pre-painted clinched assemblies for electrical noise reduction. Conductive path was achieved by texturing the sheetmetal housings prior to paint and clinching. End result: stamped clinching cheaper to manufacture over existing rivet technology while minimizing electrical noise to acceptable limits. Avantec Vascular Sunnyvale, CA

Principal R&D Engineer Mar. 2023-May 2023

• Solved stress-cracking problem in atherectomy device. Replaced brittle clear ABS material with more ductile Nylon material. Tested through accelerated aging, and worst-case loading that solution worked. Credence Medsystems Menlo Park, CA

Principal R&D Engineer Dec. 2015-Feb. 2023

• Harpoon/Catcher: Overhauled design of safety syringe’s needle capture assembly to resolve a 2% product failure rate while still achieving a 5% net BOM cost reduction. Failures resulted from the harpoon buckling upon retraction. Devised innovative I-beam for the harpoon to increase stiffness, while allowing for drug to flow, utilizing an industry-first sheet metal stamping process. Updated the harpoon to increase cross sectional capture area. As a result, product reliability increased from 98% to 100%, which was crucial to market viability. Design was patented, reduced part count from 17 to 15, and opened a new innovative product family of two-part drug mixing syringes. On a team of two, designed catcher component for catching the harpoon with low force, but hook and retain the harpoon with 10X the insertion force.

• Needle Latch: Recognized unnecessary complexity in the lower needle hub assembly of the retracting syringe product and redesigned it, achieving a 20% BOM cost reduction. My design reduced part count from 5 to 4 and assembly steps from 3 to 1 by replacing a sheetmetal component with integrated groove and snap features. Validation proved challenging due to dimensional and material constraints as well as a 2 lbf retention force requirement. Through analysis and rapid prototyping, I proved feature capability for product release, which prompted adoption of an assembly line overhaul prior to launch. My design was patented and the BOM savings were realized at a 60 part/minute production rate.

• Smart Grip for Diabetes: Technical lead for new smart finger flange product geared towards Diabetics which digitally recorded amount of insulin delivered by user into the cloud. Delivered mechanical and electro- mechanical design, incorporating rollers and magnetic sensors to measure amount of plunger travel accommodating challenging syringe form factor. Used Arduino development platform and magnetic sensor to show roller concept was capable of reading dose accuracy within 5 Units. P: 650-***-****

E-mail: *********@*****.***

Linked In Profile: https:// www.linkedin.com/in/mina-leung-346313/ Design Portfolio: https://docs.google.com/presentation/d/1rrLPd5pRQe8n9TSokx2xm4UODHNZLg76d4jCRdtFGFE/ edit?usp=share_link

• Wire Form Spring Latch: Developed triggering mechanism that reduced part count in safety syringe system back end from 11 to 4. Mechanism required a low triggering force of 1.4 lbf releasing a much larger stored spring force of 5 lbf.

• Needle Hub Retention: Developed sheet metal retaining clip for attaching syringe needle assembly to off- the-shelf glass syringes with <.0015” sloped retention bump. Force required to remove needle assembly from glass syringe was greater than 40 lbf and ended in glass breakage. AsanteSolutions/Bigfoot Biomedical Sunnyvale,CA Senior Mechanical Engineer Aug.2012-Dec.2015

• Architected new insulin pump for insertion of a new type of Insulin cartridge, Novolog. Led weekly meetings, design reviews, data reviews, requirements specifications with a team of 5+.

• Redesigned 2 gears to deliver the correct amount of insulin using the same drive mechanism as existing pump. Used custom involute gear profile to improve contact ratio, thus ensuring smooth insulin delivery.

• Designed housings and gear cover for new insulin pump. Designed new tubing connector attaching insulin from pump to infusion site on patient. Tubing connector needed to adapt to both existing Humalog pump and new Novolog pump. Reduced part count from 6 to 4 and eliminated glue from the assembly.

• Worked on next generation product with improved industrial design. Led weekly meetings with a team of 5+ to come up with concepts. Worked closely with Marketing to accommodate ID to existing product, and to introduce much needed integrated belt clip to pump to compete with competitive products. Intuitive Surgical Sunnyvale, CA

Senior Mechanical Engineer Jan. 2012-May 2012

• Camera instrument product was failing cleaning testing and root cause was unclear. Design had poorly functioning seal, and was missing critical flushing mechanism for cleaning. Designed and created transparent prototype with different flushing and sealing options for cleaning testing. Tests revealed root cause were two areas of tight clearance (distal sock/monotube interface and monotube/metal shaft interface at 5 degree bend) where blood was getting caught. Discovery led to redesign effort of camera instrument for improved cleaning.

• Chemical verification of cleaning required extracting remaining protein off of cleaned instruments., Extraction method was inefficient, and too prone to error magnification due to large volume of instrument versus small extract volume required. Experimented with various techniques of extracting the product including vortexing and percolating. Refined process of aspirating elution to foam up small volume of extract (5 mL) to evenly cover 17 mL volume. Recovery efficiency was high-76%. Intuity Medical Sunnyvale, CA

Mechanical Engineer 2009-2011

• Responsible for mechanical design of battery contacts, PCBA, display, and trigger and vacuum pin interface for all-in-one opto-mechanical glucose meter capable of reading a patient’s blood glucose in a single touch of the finger. Meter design was submitted as part of a 510(k) submission (FDA’s pre- market notification) in June 2011.

• Previous battery contacts were difficult to assemble into the device, and were prone to yield after drop. Performed mechanical redesign of battery contacts to accommodate full range of AAA battery sizes, and for prevention of yield upon drop. New battery contacts streamlined assembly process, were cheaper to produce, and were more yield resistant than previous contacts. D2M Inc. Mountain View, CA

Mechanical Design Engineering Consultant 2008-2009

• Delivered design architecture for pediatric asthma inhaler for client. Setup of pilot line for UV water filter at offshore contract manufacturer.

Abbott Diabetes Care Alameda, CA

Mechanical Design Engineer 2005–2008

• Lead Mechanical Engineer on two major products launched in 2007 and 2008: FreeStyle Freedom Lite’ and ‘FreeStyle Lite’ glucose meters.

• Improved mechanical design of glucose monitors over previous devices, resulting in lower cost design, and increasing US market share to 15%, and fewer problems in the field: Designed first successful, strong snap fit case enclosure design, and first successful rubber over-molded case design. Incorporated user feedback with designed in larger LCD icons, rubber over-molded design, and larger buttons with tactile feedback.

• Led team of engineers and drafters to develop engineering drawings, performing tolerance analysis, and conduct verification testing.

Guidant Cardiac Surgery Santa Clara, CA

Mechanical Engineer 2001-2005

• On a team of 2 mechanical engineers, performed mechanical and industrial design on cardiac bypass vacuum stabilizer product. Due to redesign, products were elevated to 2nd place market share in the off- pump surgical market share. Market share grew from 20% to 40%.

• Solicited and incorporated feedback from surgeons and sales representatives to improve vacuum foot component, which was responsible for greater usability of product. Designed complex insert molded, over- molded vacuum “foot”. Developed new vendor and adhesion process to adhere over- molded malleable foot to metal insert.

• Designed (on a team of 2) universal mount mechanism on stabilizer product. Mechanism is responsible for mounting stabilizers on a multiple of chest retractor platforms as well as proprietary Guidant retractor. Mechanism successfully helped regain market share. Studio Red MenloPark,CA

Mechanical Engineer 2000-2001

• Interacted with industrial designers and performed mechanical design on network bezels, medical device packaging, and scientific instrumentation.

Capstone Turbine Corporation Reseda, CA

Test Engineer 1997-1998

• Designed data acquisition programs for testing rotary flow compressor. Education

Stanford University Stanford, CA

• M.S., Mechanical Engineering

California Institute of Technology Pasadena, CA

• B.S.,Engineering and Applied Science (emphasis in Mechanical Engineering) Knowledge/ Skills

SolidWorks, PDMWorks, SolidWorks Simulation (FEA package), Pro/ENGINEER, advanced surfacing, mastermodel technique, CETol, tolerance analysis, Instron, Blue Hill, LabWindows, FEA, FAI, JMP, statistics, Minitab, Matlab, Manual Machining, 2.5, 3, and 4th axis CNC Machining, laser welding, laser- cutting, capital equipment, stamped sheetmetal, 3D-printing, injection molding, VisualCAM, project management, verification testing, design control documentation, GD&T, ANSI Y14.5, electro-mechanical design, ISO 15883, IEC 60601. Patents

• US Patent No. 10,912,894, 10,926,038, 11,541,179, 11,712,525, 11,844,937, 11,707,578, 11,759,577

• US Patent Application No. 16/837,835, 17/169,778, 17/574,279, 18/091,959, 17/895,998, 63/330,415

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