SUMMARY

• Hands - On Product developer, with 30 Years in the development of biomedical products & hearing aid and wearable devices.
• 71 issued patents and 1 pending patent.
• Strong medical device background developing stent, catheters and infusion pumps.
• Start-up experience with InSound Medical developing the first CIC hearing aid.
• Secured FDA approval through 510K on the Lyric hearing device, currently the world's smallest and only extended wear hearing product on the market.
• The Lyric product is a recipient of several prestigious s including Top CNN Health Innovations of 2009; Popular Science Magazine Best of What is New, and Medical Design Excellence by MDDI.
• Strong Computer Aided Design, FMEA and SoldWorks experience. Also experienced in micro injection molding/sheet metal and has a broad understanding of bio-compatibilities materials, and manufacturing experience in medical device specifications.
• Complete understanding of FDA, TUV, FCC and CSA, (G.D.T.) Geometric tolerance, cGMP, Manufacturing Process and ANSI standards Y14.5M.
• Experience also includes DFM/DOE and Verification Validation. ISO 13485 Medical Devices to complete device packaging and end of life cycle and working with all external suppliers.
• Passionate about leading high-performance teams to develop sophisticated technologies in the medical device and consumer products industries.
• My technical focuses are on mechanical and Miniaturized Electronic designed on a Flex PCB, particularly high-volume micro injection molded products. I have lived the entire product development life cycle from concept through end of life, manufacturing, full-scale production, sustainment, service.

PROFESSIONAL EXPERIENCE

Sr Product Development Engineer

Confidential, Hayward, CA

Responsibilities:

• Designed a Hearable/Wearable in ear device using 4.2 Bluetooth capabilities, program firmware code using Spy interface using CSR source code platform & developed proprietary algorithms.
• Working with external suppliers, from PCB Fab house/component distributors/injection mold tools, and also managing consultants to successfully design working prototypes that are at Pilot stage.
• Working prototype consists of:
• CSR 8670 has a DSP/Codec
• CSR 8670 classic Bluetooth 4.2 to 5.0 TWS
• NFMI antenna using the NXP Chip interface with CSR processor
• CSR 8670 ANC capabilities
• CSR 8670 BLE capabilities
• NXP- NFMI communication to stream in stereo from right to left device
• Unique Miniaturized Electronic Flex 8-Layer PCB design
• Bluetooth Antenna design
• Tap-Sensor using an accelerometer Tap functions
• Utilizing existing AI platform
• Used Altium for PCB architecture layout
• Used Solidworks to design 3D models, tooling and perform FMEA/3D Printing
• Used Python/SPY/I2C for firmware development
• 7 Patents granted Hearable/Wearable/biometric monitoring and Hearing Aid Patents, 1 pending

Confidential, Hayward, CA

Product Developer

Responsibilities:

• Designed a wearable in ear Buds using the CSR 8670 chip with 4.1 Bluetooth capabilities developed the program code through Spy interface.
• Successfully designed a working prototype in 5 months to successfully secure Angel funding of $4 M.
• The working prototype consists of:
• CSR 8670 has a DSP/Codec
• CSR 8670 classic Bluetooth 4.1 TWS
• CSR 8670 also has ANC capabilities
• CSR 8670 also has BLE capabilities
• Miniaturized Electronic designed on a Flex PCB
• Bluetooth Antenna design
• Accelerometer (Step count/Tap functions)
• Removable Cap Disposable battery 6 hour of usage with membrane protection
• Designed replaceable Seals with membrane protection (XSmall /Small/Medium/Large/XLarge)
• Worked with a team on the development of our own AI platform
• 22 Patents accepted wearable/biometric monitoring/AI Earbud.

Confidential

San Leandro, CA

Responsibilities:

• Designed a100% invisible extended wear (CIC), hearing device that is completely in the ear canal.
• Working with all external suppliers, and managed consultants to successfully design working products currently being sold in the market,
• Designed all test fixtures to help characterize our seals and designed custom seal molds, implemented a process for nano-coating to allow for the device to be submerged up to 3 feet under water.
• Filed a 510(k) to allow for OTC hear test. Successfully obtained Declaration of Conformity (CE mark).
• Followed ISO 13485 Medical Devices .
• Led the design development and cross-functional teams from EE engineers and software, outside vendors, manufacturing, business development and marketing functions to meet company goals.
• Hearing aid high-performance electro acoustic design, allowing for excellent sound quality with no feedback, also designed our own preparatory seal to eliminate the occlusion affect.
• Using an ultra low-power On-Semi chip (SB3229 ) circuitry in combination with a proprietary DSP algorithm and replaceable battery to provide continuous operation for one week.
• This is a 100% Invisible (CIC) to accomplish the design intent to make it invisible to remove the stigma associated with having hearing loss.
• The design is used as a daily wear, such as showering, sleeping, exercising, and talking on the phone, so hearing is uninterrupted.
• The Placement of the device and custom seals captures natural sound - in the ear’s to helps direct sound in the ear canal, creating a natural sound quality.
• 42 Patents accepted hearing aid technology.

Confidential, Newark, CA

Validation specialist

Responsibilities:

• Assisted on the development of the Lyric, from the foam seals/custom battery/ Miniaturized Electronic designed on a Flex PCB. Made recommendations and implemented processes for repe Confidential bility.
• Build a DHF directory, created a standard drawing format with standard note, designed a bill of material Via SolidWorks,
• Coordinated and wrote SOP, test methods, risk analysis and verification and validation reports.
• Developed tooling fixtures to support the production line, based on MPI for manufacturing processes.
• Designed micro ejection molded parts and selected polymer for Biocompatibility for contact in the ear canal, reduce cost to keep in line with the COGs.
• Collaborated with an internal cross-functional team, 3rd party design partners and suppliers.
• Created an ERP system from scratch to track cost and product tractability.
• Followed ISO 13485 Medical Devices .

Confidential, Morgan Hill, CA

R & D System Development Designer

Responsibilities:

• Converted existing infusion pumps to dispense a drug through an IV to wireless communication.
• Detailed and designed plastic injection molded enclosures, sheet metal parts, fluid seals, and wiring harnesses. Designed assemblies for protection from shock, vibration, and EMC/ESD/EMI.
• Wrote protocols and tested for verification for engineering and validation through manufacturing in support of a new product release.
• Communicated and collaborated with an internal cross-functional team, 3rd party design partners and suppliers.
• Generated ECO's for documentation release for FDA approval.

Confidential, Santa Clara, CA

Senior Manufacturing Equipment Developer

Responsibilities:

• Provided technical assistance and design support from tooling to system product with a project team of engineers that developed an application for drug coating stents.
• Developed and implemented a Q.C. station for a radiation chamber to inspect radiated source wire.
• Process developed for manufacturing and pilot build to improved yields from 20% to 80%, decreased turnaround time by 75% and reducing floor space by 65%.
• Redesigned and implemented mandrel loosener head. Achieved loss reduction from of 80% to 3% with a cost savings of $3 to $4 M per year.
• Provided technical and documentation assistance, designing from tooling fixtures to system product development, with engineering project team
• Delivered systems and supporting documentation to manufacturing by release date for FDA approval and laser safety.
• Implemented a redesign of an eight-jaw servo crimper because system down time was 92% and there was 85% difficulty for repeat build and calibration. After redesign, the down time reduced to 5% for maintains only and 2% for difficulty of reassembly and calibration.
• Designed tooling and documentation for several projects including a fully automated system for laser cutting device.
• Released documentation for validation and assemblies for incoming inspection.
• Generated the documentation for hardware validation and qualification, along with all the detail drawing to support the release of products for FDA approval using DOP32 and Build a DHF director
• Coordinated and wrote SOP, test methods, risk analysis and verification and validation reports.
• Followed ISO 13485 Medical Devices .

Confidential, Santa Clara, CA

Senior Mechanical Engineer

Responsibilities:

• Developed and implemented, with project team of engineers, a 200-DVD changer; manufactured in Dongguan City, Shenzhen, China.
• Developed rapid tooling for sheet metal and ejection molds.
• Set up process control parameter for the production line, for incoming inspect and validation to support product release.
• Documented appropriate G.D.T. tolerance for fabricating sheet metal, rapid tooling, ejection molds and die stamps parts.
• File management of all-electronic files to keep the main layout current and files in order.
• Established controlled drawings for PCB cable assemblies and component specifications supporting all products and repeat builds.

TECHNICAL SKILLS

• SolidWorks 98 through 2020: Modeling: Simulations, Tolerance Analysis, Finite Element Analysis (FEA).Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, and statistical analysis and Design of Experiments (DOE) Design Controls for regulatory compliance & filing (ISO 13485): GMP, Design History Files, protocols/reports, hazards analyses, batch records.
• Altium pcb layout design Six years experience, UNIX, Windows, Microsoft Word, Microsoft Excel, CSR-Tools/applications running on win/IDE/Sink Configuration/VMSpy/PStool/BlueFlash/BlueTest for development and debug, and 15 years of experience on writing Patent applications.