Bob Silva

Bob Silva Email and Phone Number

Sr Director Of Engineering, Medical Devices @ MEDIcept Inc.
Bob Silva's Location
Newbury, Massachusetts, United States, United States
About Bob Silva

VP / Executive Director with domestic and international medical device development experience as an engineering executive managing collaborative engineering teams designed to effectively create customer focused solutions. Engineering Leadership• Lead and develop highly trained, creative, motivated engineering teams capable of thinking “Outside the box”• Ability to mentor and create highly engaged technical management teams• Experience in design and development with ability to maintain a strong pipeline of top technical talent• Collaborative experience with Quality, Regulatory, Product/Project Management, Clinical, Supply Chain• Controlled R&D budgets to ensure product development within expected budgetary constraintsMedical Device Full Lifecycle Development• Demonstrated deep understanding of medical product lifecycle design in a regulated environment.• Work with and implement under FDA and MDD regulations, company policies, standard operating procedures, and processesStrategic Thinking • Management of highly technical solutions that are applied to customer specific problems• Experience with integrating legal with product lifecycle in support of intellectual property portfolio

Bob Silva's Current Company Details
MEDIcept Inc.

Medicept Inc.

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Sr Director Of Engineering, Medical Devices
Bob Silva Work Experience Details
  • Medicept Inc.
    Sr Director Of Engineering
    Medicept Inc. Mar 2023 - Present
    Boston, Ma, Us
    Day-to-day management and leader of the Systems and Software Quality Engineering department. This includes the oversight of projects and resources working with various customers / clients, project and department budgets, and collaboration with various levels of the MEDIcept organization.
  • Dräger
    Sr Director Of Engineering
    Dräger May 2019 - Feb 2023
    Lübeck, Schleswig-Holstein, De
    Recruited to manage a 120-member team of co-located software engineers responsible for support of existing monitoring product line as well as introduction of next generation patient monitoring system.• Restructured software team geared toward customer centric product development strategy• Collaborated and directed the integration of monitoring to interoperate with other Draeger medical platforms• Managed Draeger’s Warning Letter CAPA geared toward restructuring the design control process to be in line with regulatory / FDA expectations.
  • Kmc Systems
    Director Of Engineering
    Kmc Systems 2013 - Apr 2019
    Merrimack, New Hampshire, Us
    Hired to manage the hardware and software engineering teams on multiple, simultaneous projects • Managed a multi-disciplined 60-person team of R&D engineers geared to the commercial design and development of Invitro-Diagnostics• Directed multiple programs simultaneously with large scale customers that included collaborative design and development of systems from concept to release to manufacturing. Programs varied in size from 15 to 50 driving concept, breadboards, requirements, design, development, and transfer to manufacturing.• Worked with executive management to generate and submit proposals to Abbott, BD, Roche, GE, IL and Biomerieux, winning jobs from each of these customers resulting in developments costs from $12M to $70M
  • Fluidnet
    Vp Of R&D
    Fluidnet Oct 2011 - Mar 2013
    North Andover, Ma, Us
    Recruited into a startup engineering environment to build the engineering infrastructure to support development of a novel infusion pump• Managed a multi-disciplined team of R&D engineers geared to the commercial design and development of infusion pumps. Included R&D P&L responsibility for a team that consisted of up to 30 engineers.• Demonstrated ability to ramp up from a scientific environment to one that met regulatory requirements and was customer focused.
  • Infraredx, Inc.
    Vice President Of Research & Development
    Infraredx, Inc. Mar 2005 - Oct 2011
    Bedford, Massachusetts, Us
    Hired to recruit and manage a multi-disciplined team of R&D engineers geared to the commercial design and development of systems used to detect vulnerable plaque in coronary arteries. • R&D P&L responsibility for a team that consisted of up to 30 scientists and engineers.• Managed a cross-functional team in the design and development of a system based on Near Infrared Spectroscopy coupled with Intra Vascular Ultrasound (IVUS) including the algorithm development to convert from white paper descriptive format to a commercialized system.
  • Haemonetics Corp / Transfusion Technologies Corp
    Director Software Engineering
    Haemonetics Corp / Transfusion Technologies Corp Jan 1994 - Jan 2005
    Boston, Ma, Us
    Recruited to provide architecture design and development of software for the next generation aphaeresis device• Worked with the team to develop and get 510(k) approval of a completely new cell collection system
  • Symbiotics, Inc
    Vp, Software Development
    Symbiotics, Inc Jan 1989 - Jul 1994

Bob Silva Skills

Medical Devices Design Control Product Development R&d Cross Functional Team Leadership Fda Iso 13485 Strategy Biomedical Engineering Electronics Product Launch Engineering Commercialization Manufacturing Quality System Validation Start Ups Embedded Systems Leadership Software Development V&v Engineering Management Testing Embedded Software Management Software Engineering Design For Manufacturing Design Of Experiments Gmp Market Development Capa Integration Hardware Diagnostics Root Cause Analysis Labview Quality Management Iso Fmea Six Sigma Medical Imaging Process Simulation Quality Assurance Systems Engineering Manufacturing Engineering Medical Device Startups Image Processing

Bob Silva Education Details

  • Northeastern University
    Northeastern University
    Computer Science

Frequently Asked Questions about Bob Silva

What company does Bob Silva work for?

Bob Silva works for Medicept Inc.

What is Bob Silva's role at the current company?

Bob Silva's current role is Sr Director Of Engineering, Medical Devices.

What is Bob Silva's email address?

Bob Silva's email address is bo****@****ger.com

What is Bob Silva's direct phone number?

Bob Silva's direct phone number is +197846*****

What schools did Bob Silva attend?

Bob Silva attended Northeastern University.

What skills is Bob Silva known for?

Bob Silva has skills like Medical Devices, Design Control, Product Development, R&d, Cross Functional Team Leadership, Fda, Iso 13485, Strategy, Biomedical Engineering, Electronics, Product Launch, Engineering.

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