David J Burke

David J Burke Email and Phone Number

Device Design Alchemist @ Takeda
Lexington, MA
David J Burke's Location
United States, United States
David J Burke's Contact Details

David J Burke personal email

n/a
About David J Burke

Design engineering maven with a lifetime of experience in the design and clinical implementation of Class III medical devices. Demonstrated success creating designs that brought a portfolio of innovative cardiac devices from concept to FDA approval.

David J Burke's Current Company Details
Takeda

Takeda

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Device Design Alchemist
Lexington, MA
Website:
takeda.com
Employees:
36992
David J Burke Work Experience Details
  • Takeda
    Takeda
    Lexington, Ma
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  • Planetburke Skunk Works
    Device Design Alchemist
    Planetburke Skunk Works Sep 2023 - Present
    Pie in the sky? Pie in geosynchronous orbit? Not a problem! We bring med-tech device ideas down to earth and make them happen.
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  • Takeda
    Device Development Lead
    Takeda Sep 2017 - Sep 2023
    Tokyo, Jp
    Function as the technical lead on several projects within the Device Development Group at Takeda. This includes cross functional responsibilities with the development of new devices as well as qualification of commercially available devices used with Takeda drug products.
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  • Flow Forward Medical, Inc.
    New Product Development Consultant
    Flow Forward Medical, Inc. Jun 2017 - Sep 2017
  • Philips Healthcare
    Senior Manager, Hardware R&D Engineering
    Philips Healthcare 2015 - 2017
    Amsterdam, Noord-Holland, Nl
    Responsible for leading a team of electrical, mechanical, firmware and project engineers dedicated to sustaining and new product engineering within the Emergency Care Resuscitation (ECR) organization at Philips Healthcare.
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  • Thoratec Corporation
    Principal Engineer
    Thoratec Corporation 2008 - 2015
    Pleasanton, Ca, Us
    Functioned as technical lead and primary designer of all hardware and software components developed for the second generation of the HeartMate II (HMII) Left Ventricular Assist Device (LVAD) System Controller.
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  • Thoratec Corporation
    Senior Manager Of Technology Development
    Thoratec Corporation 2005 - 2008
    Pleasanton, Ca, Us
    Planed, managed and technically directed all of the electronic and software design projects within the Thoratec HMII development group. Established and maintained standards of technical performance by writing and maintaining operating procedures as well as verifying that all design activities were performed in compliance with ISO 9000 and any other relevant directives. Functioned as a multi-disciplinary technical liaison to customers, clinicians and other departments. Directed the electrical and software aspects of continuing engineering activities for products in clinical use.
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  • Thoratec Corporation
    Senior Manager Of Electrical And Software Engineering
    Thoratec Corporation 2001 - 2005
    Pleasanton, Ca, Us
    Designed and supervised development of all the electronic and software components of the first generations of the Heartmate II LVAD and the Heartmate III sealed system subassemblies.
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  • Thermo Cardiosystems
    Manager Of Electrical Engineering
    Thermo Cardiosystems 1991 - 2001
    Planed, managed and technically directed the development and implementation of all software and processing hardware embedded in, or used with the Thermo Cardiosystems (TCI) family of products. Completely revised the software development and validation procedures to meet international standards.Designed the electronic hardware, software and user interface for the second-generation Heartmate Vented Electric LVAS System Controller. Designed and supervised development of the bedside system monitor which served as the primary clinical interface for the Heartmate assist systems.

David J Burke Skills

Medical Devices Fda Biomaterials R&d Biomedical Engineering Design Control Validation Iso 13485 Design Of Experiments Product Development Software Development Capa Cross Functional Team Leadership Healthcare Software Design Ventricular Assist Devices V&v Hospitals Cardiology Research And Development

David J Burke Education Details

  • Northeastern University
    Northeastern University
    Bachelor Of Science (Bs) Biology / Chemistry

Frequently Asked Questions about David J Burke

What company does David J Burke work for?

David J Burke works for Takeda

What is David J Burke's role at the current company?

David J Burke's current role is Device Design Alchemist.

What is David J Burke's email address?

David J Burke's email address is da****@****eda.com

What schools did David J Burke attend?

David J Burke attended Northeastern University.

What skills is David J Burke known for?

David J Burke has skills like Medical Devices, Fda, Biomaterials, R&d, Biomedical Engineering, Design Control, Validation, Iso 13485, Design Of Experiments, Product Development, Software Development, Capa.

Who are David J Burke's colleagues?

David J Burke's colleagues are Amós Ventorin, Anisha Pola, Marek Macko, Mohamed Galbat, Michael Sullins, Christopher Ngo, Tomáš Koňár.

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