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Experienced Product Development Executive with 30+ years in molecular diagnostics, cell-based assays, and semiconductor automation. Proven track record driving innovation and results. Skilled in Executive Leadership, Project Management, Quality, IVD Regulatory Requirements, Microfluidics, Design Controls, DFM, and much more. Adept at leading cross-functional teams to deliver cutting edge successful products.
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Vice President Of EngineeringNuclein Sep 2023 - Nov 2024Austin, Tx, UsLed Engineering team in design transfer of a Clia-Waived point-of-care molecular IVD Instrument and Test.• Design Verification and Validation• Implementation of manual assembly lines, Manufacturing and Quality Test Instructions, DHRs• Equipment and Line Validations (IQ, OQ, PQ)• Risk Assessments (dFMEA, pFMEA)• DMR Documentation Package• Planning and specifications for fully automated line for consumable device.• Implementation of sub-5% RH assembly environment. -
Engineering ConsultantThermo Fisher Scientific Jan 2023 - Apr 2023Waltham, Ma, UsProvided technical guidance to the team in the development of a next generation point-of-care molecular diagnostic platform and microfluidic consumable device. -
Sr. Director, Product DevelopmentThermo Fisher Scientific Feb 2021 - Jan 2023Waltham, Ma, UsMesa Biotech was acquired by Thermo Fisher Scientific in February 2021. With the demand for Covid-19 tests, the organization grew from ~55 employees (Jan 2020) to over 2,000 (current). Operations were scaled from ~50,00 tests/mo to now > 2MM/mo. I am leading all Engineering efforts in the development of next-generation, cloud-connected molecular diagnostic (RT-PCR) test platform and consumables.• Managing a department of 16 Engineers, including Mechanical, Electrical, and Software.• Overseeing instrument development collaboratively between local and overseas teams.• Designing new novel microfluidic test cassette to achieve rapid PCR cycling, reduced time to result (TTR), low COGS, and DFM.• Key source of legacy technical experience as the organization grows under Thermo Fisher umbrella.• Executive and Corporate development updates.• Facility and resource planning.
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Vice President Of Engineering & Product DevelopmentMesa Biotech, Inc Sep 2017 - Feb 2021San Diego, California, UsLead a cross-functional team in the development of the Accula point-of-care molecular diagnostic test platform. Responsible for all aspects of the development process including project management, design controls, product requirements, technical oversight, verification and validation, facility planning, and recruiting. Worked closely with Quality Assurance to ensure product quality and regulatory compliance. Awarded 510(k) and CLIA-Waiver for a number of RT-PCR tests including Flu A/B, RSV, Strep-A, as well as rapid development and EUA of our Covid-19 test. -
Director Of EngineeringMesa Biotech, Inc Jun 2015 - Sep 2017San Diego, California, Us
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Sr. Director, EngineeringAcea Biosciences Jan 2004 - Apr 2015San Diego, California, UsManaging a multinational Engineering team in the development of a novel line of real time, label-free, non-invasive cellular analysis products. Responsibilities include department management, project planning, production oversight, mechanical design, and coordination with external international development partners. -
Principal Mechanical EngineerNanogen Mar 1999 - Jan 2004Lead the engineering development of Nanogen's Electroscreen Workstation, an innovative automated high throughput screening instrument purposed for the identification and analysis of kinase reaction inhibitors for drug discovery.Additionally collaborated in the development of various benchtop and portable lab-on-a-chip genetic diagnostic test systems.
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Team Leader, Vacuum ProductsSmart Machines, Inc Oct 1994 - Sep 1998#2 employee of startup semiconductor equipment manufacturer. Lead a cross-functional team in the development of various vacuum-compatible automation systems including a three-axis high performance direct drive wafer transfer robot, substrate aligner, and active gripping end effector. Responsibilities included Team Management, Project Management, Design and Document Control, Pro/Engineering Database Administration, and UNIX administration.
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Pro/Engineer Design ContractorMattel Toys & General Atomics May 1994 - Oct 1994Complex Pro/Engineer design including advanced Pro/SURFACE feature generation. Contracts held with Mattel Toys and General Atomics.
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Mechanical Lead EngineerHughes Network Systems Jun 1992 - 1994Germantown, Md, UsDesigned an in-flight telephone/entertainment system for commercial airlines. I was responsible for all phases of the product development cycle from conceptual design, analysis, testing, detailed design and vendor interfacing to manufacturing support. Design work included modeling of complex injection molded plastic parts as well as sheetmetal and machined parts. Also designed and implemented automatic test fixtures and performed extensive vibration testing of products.Gained valuable experience in advanced feature modeling with Pro/Engineer. -
Engineering InternWalt Disney Imagineering Jan 1991 - Jun 1991Glendale, California, UsPlanning, setup, and execution of various design validation studies on a full-scale mockup of Splash Mountain conveyor system.
Donald Thomas Skills
Donald Thomas Education Details
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California Polytechnic State University-San Luis ObispoMechanical Engineering -
Livermore High SchoolGeneral Studies
Frequently Asked Questions about Donald Thomas
What is Donald Thomas's role at the current company?
Donald Thomas's current role is Accomplished Product Development Executive. Skilled at growing teams and delivering new cutting edge technologies..
What is Donald Thomas's email address?
Donald Thomas's email address is dt****@****ech.com
What schools did Donald Thomas attend?
Donald Thomas attended California Polytechnic State University-San Luis Obispo, Livermore High School.
What are some of Donald Thomas's interests?
Donald Thomas has interest in Science And Technology, Health.
What skills is Donald Thomas known for?
Donald Thomas has skills like Product Development, Cross Functional Team Leadership, Engineering, Biotechnology, Manufacturing, Mechanical Engineering, Automation, R&d, Testing, Project Management, Validation, Medical Devices.
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