Duane Yamasaki Email and Phone Number
Medical Device Executive -Product Development- From Lab through Commercial Launch and Acquisition. at
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Proxim Diagnostics
Duane Yamasaki's Location
San Francisco Bay Area, United States, United States
Duane Yamasaki's Contact Details
Duane Yamasaki work email
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Duane Yamasaki phone numbers
About Duane Yamasaki
Create corporate value by developing products from research feasibility through commercialization. Organizing efficient cross functional teams and growing the business from startup through acquisition.Business Development and Product Realization. Understanding how it can be done and executing on it. Keen insight toward assessing feasibility of Medical device/diagnostic new product development, product introduction and manufacturing process development. Design for manufacturability, equipment procurement, installation, qualification and validation. Building efficient operations and logistics with contract manufacturers.Direct responsibility for operations P& L. Solid practice and understanding of product/process Failure Mode Effect Analysis (FMEA), data analytics, data visualization and DOE’s for characterizing, developing, and evaluating proof of principle models and high volume mass production manufacturing processes.
Duane Yamasaki's Current Company Details
Proxim Diagnostics
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Medical Device Executive -Product Development- From Lab through Commercial Launch and Acquisition.
Duane Yamasaki Work Experience Details
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Vice President Of Product EngineeringProxim Diagnostics Feb 2023 - PresentSanta Clara, California, UsEarly stage development of product requirements, for an electro-chemical immuno assay detection platform for the point of care market. Development of reader instrument and disposable test cartridge product and manufacturing process development.
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Vice President Of EngineeringLucira Health (Ipo - Acquired By Pfizer) Dec 2021 - Feb 2023Developing new bacterial moldecular diagnostic platform for the over the counter at home use. Developed and launched two NPI for Covid-19 FLU A and B over-the-counter at home molecular diagnostic platforms in 6 and 3 month time frames for Health Canada and under EUA for US. Developed and scaled up reagent, lyophilized pellet manufacturing process. Constantly developing and improving internal pilot device assembly manufacturing capabilities for multiple development assay platforms. Delivered a second set, quantity of 7, 16-cavity injection mold tooling doubling daily capacity. Additional responsibilities also included managing two sets of Automation programs; Semi-automation to supplement manual contract manufacturing processes and a full turnkey high volume internal program.
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Vice President Of OperationsProof Diagnostics (Acquired By Ginkgo Bioworks) Oct 2020 - Dec 2021NPI for a Covid-19 POC molecular diagnostic platform. Developed the manufacturing process for the disposable cartridge during the design transfer process from the product design contractor to the outsourced high volume (1MM + /mo.) manufacturing contractor. Built a team of engineers to transfer design, develop and scale manufacturing process for the outsourced cartridge and reagent manufacturing. Regulatory strategy is an EUA submission. Also responsible for nstrument design transfer and manufacturing development to a high volume instrument manufacturing supplier.
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Vice President Of EngineeringSythomics (Privately Held) Sep 2018 - Oct 2020Developed high through-put bench top DNA/RNA synthesizer. Responsible for all aspects of engineering and development of a bench top instrument. Proof of concept through prototype design development and working feasibility models. Identified contract development firms to construct working demo units. Responsible for software/firmware development. Participated with fundraising activities.
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Vice President Of EngineeringZip Diagnostics - Acquired By Zoetis Feb 2017 - Sep 2018Develop integrated Lab on a chip bio-sensor. Utilizing CMOS technology for an immuno based diagnostic testing platform. Lead all engineering, product process development from research base inception at UC Berkeley's QB3 incubator through product/ manufacturing process development and acquisition .
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Co-Founder, Vice President Of Operations And EngineeringCoagusense Acquired By Isens Dec 2008 - Jan 2017Executive leader - formed engineering and operations teams leading Coagusense from start-up through successful clinical trials, FDA approval 2010, and commercial operations. .Scaling up manufacturing for commercialization from ground up.Hired and mentored all operations staff.Building high performance relationships with suppliers and CMOs.Direct responsibility for P and L
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Sr. Supply Chain ManagerTheravent, Inc. (Privately Held) Sep 2007 - Dec 2008San Jose, Ca, UsLead Product development efforts of Ventus' (OTC Anti-Snoring Device). Sourced clinical CM through high Volume OEM CM. Reduced COGs by 71% from initial design to meet corporate margin target. Independently selected the prototype and contract manufacturing suppliers to support Venuts’ virtual company business model. -
Sr. Manufacturing EngineerSpinal Kinetics (Acquired By Orthofix) May 2006 - Aug 2007Developed manufacturing process for an implantable cervical disc replacement device and surgical tooling system. Product development included device DFM and proof of principle testing for assembly and fixturing for pilot and clinical manufacturing of devices. This included the development of a laser welding process and specifying and procuring a laser system for welding Titanium implant parts. Lead surgical instrument contract manufacturing development and packaging efforts. Assisted in defining new facility design requirements and build out.
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Manufacturing Engineering ManagerFarallon Medical (Privately Held) May 2005 - May 2006Joined a nine person early stage start-up to develop Farallon Medical’s Immedia Prothrombin Time Monitoring system and disposable test strips. Refined and improved meter operation and efficiency of clot detection system and software algorithms. Manage contract engineering resources for meter Industrial Design and PCB design. Identified coordinated contract manufacturer for meter PCB fabrication. Managed outsourced injection molding of plastic meter components. Designed, developed and built strip reagent dispensing platform for manufacturing disposable strip.
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Staff Process EngineerAlexza Pharmaceuticals (Ipo) May 2004 - May 2005Fremont, California, UsManaged Production of Toxicology Materials for Combinational Pharma/Device delivery systems. Developed toxicology proof of concept models for 4 inhalable drug platforms. This includes active pharmaceutical ingredient (API) coating development, characterization, and equipment development. Prepare manufacturing section for IND submission. Commercial Product Development, responsibilities include product design for manufacturability and development of scalable manufacturing processes, for coating (API) and product assembly of energetic materials in a disposable inhalation drug delivery system. Contributed to the development of a multi-dose, disposable, inhalable drug delivery platform. Elements included process development for API coating, assembly, and packaging of the device. -
Staff Process EngineerTherasense (Ipo, Acquired Abbott) Feb 1999 - May 2004Responsible for designing and developing a scaleable manufacturing process for TheraSense’s implantable continuous glucose sensor. Propelled project forward from lab models to working in-vivo clinical devices. Manage a group of process engineers and technicians. Setup and validated pilot manufacturing controlled environment room for preparing clinical materials on schedule. Designed, built and debugged proof of principal pilot equipment. Plan and execute capital budgets for program. Develop supplier’s capabilities in return for quality low cost components employing existing proven technologies. Wrote documents for the Manufacturing Module PMA submission.FreeStyle® Manufacturing- Developed and implemented second generation automated strip packaging line (Tripling capacity) up to 120 parts per minute. Managed contract machine builders (both domestically and in Europe) for labeling, cartoning, and case packing machinery. Machines delivered in 7 months from purchase order to floor.
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Plastics EngineerAclara Bioscience (Ipo, Acquired Monogram Biosciences) Oct 1997 - Feb 1999Successfully delivered two assays for a partnership access program by implementing robust scalable technologies in the development of disposable plastic and film substrates for high-throughput screening assays. Designed and installed a controlled environment pilot manufacturing line for producing disposable plastic “lab on a chip” technology. Technical team development contributor for micro-fluidic dispense applications. Responsible for developing quality control testing, documentation and material control system.
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Manufacturing ManagerBiocircuits Apr 1997 - Sep 1997Product and Manufacturing Process Development for Medical Devices and In-vitro Diagnostics. Developed manufacturing for 4 immunoassays Helping Start-ups finish.
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Manufacturing EngineerBio Rad Labs Jun 1992 - Apr 1997Hercules, Ca, UsResponsibilities include product/process feasibility studies, justification, development, design, and fabrication of automated production equipment for manufacturing, low cost Capillary Electrophoresis cartridge systems, HPLC columns and diagnostic reagents. Successfully scaled a five fold capacity increase in HPLC column manufacturing for 5 product lines of lab diagnostic instruments. Design, specify and commission injection mold tooling for low cost plastic assay preparation components. Automated bulk processes and QC assays and inspections. Implemented SPC to evaluate Clinical manufacturing processes. Support efforts for ISO 9001 Certification. Spearheaded quality improvements both internally and externally(suppliers) while reducing direct labor and material costs on existing manufacturing, bottling and packaging lines. Improved product quality and lowered cost by implementing SPC at supplier facilities. -
EngineerCollagen Corporation Sep 1989 - Jun 1992Responsible for designing, developing, and building aseptic PLC controlled automated production equipment for manufacturing aseptically filled and packaged protein products. Responsibilities include design justification, procuring quotes, and overseeing the fabrication, installation qualification and validation of bioreactors, process vessels and automated filling and packaging machinery. Developed, scaled and optimized a protein lyophilization process for a gamma irradiated bone graft product. Developed a custom automated aseptic syringe filling machine for two product lines with multiple product configurations (12 fold increases in capacity over existing line). Developed a Collagen protein Homogenizer increasing capacity from 600K to 1.2 Million ccs/year. Wrote documentation supporting PMA and 510 applications.
Duane Yamasaki Skills
Medical Devices
Product Development
Validation
Design For Manufacturing
Engineering
Cross Functional Team Leadership
Fmea
Executive Management
Commercialization
Start Ups
Process Engineering
Fda
Start Up Ventures
Quality System
Iso 13485
Spc
Automation
Manufacturing Engineering
Testing
Quality Control
Manufacturing
R&d
Management
Design Control
Product Launch
Lean Manufacturing
Software Documentation
Solidworks
R
Capa
Gmp
Design Of Experiments
Biotechnology
Leadership
Six Sigma
Product Management
Business Development
Process Simulation
Injection Molding
Plastics
Medical Device Product Development
V&v
Process Improvement
Biomedical Engineering
Quality Assurance
Materials
Pharmaceutical Industry
Iso
Continuous Improvement
Duane Yamasaki Education Details
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California State University-SacramentoMechanical Engineering
Frequently Asked Questions about Duane Yamasaki
What company does Duane Yamasaki work for?
Duane Yamasaki works for Proxim Diagnostics
What is Duane Yamasaki's role at the current company?
Duane Yamasaki's current role is Medical Device Executive -Product Development- From Lab through Commercial Launch and Acquisition..
What is Duane Yamasaki's email address?
Duane Yamasaki's email address is du****@****ip.life
What is Duane Yamasaki's direct phone number?
Duane Yamasaki's direct phone number is +151062*****
What schools did Duane Yamasaki attend?
Duane Yamasaki attended California State University-Sacramento.
What skills is Duane Yamasaki known for?
Duane Yamasaki has skills like Medical Devices, Product Development, Validation, Design For Manufacturing, Engineering, Cross Functional Team Leadership, Fmea, Executive Management, Commercialization, Start Ups, Process Engineering, Fda.
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