Bob Barrett Email and Phone Number
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Engineering leader and team builder with a focus on results. Technical strengths in medical device systems engineering, systems and software validation, safety risk analysis, quality management and project management. Strong believer in cadence driven project management techniques. Ability to be hands-on or leading cross-functional teams to move medical development projects from concept to market release.Specialties: medical device with software systems development, project management, systems engineering, creating and directing teams, design verification and validation, medical device software validation, medical device regulatory guidelines and processes.
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Vice President Systems Engineering And QualityFull Spectrum Jul 2021 - PresentSouthborough, Massachusetts, Us
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Company Principal Systems Engineering LeadFull Spectrum Oct 2006 - Apr 2022Southborough, Massachusetts, UsAs of January 1, 2021 Intertech Engineering is now Full Spectrum Software. Engineering functional leader specializing in driving projects requiring medical device software system design, software validation, risk analysis, compliance and systems validation and regulatory clearance. Responsible for the Lincolnshire office and all Systems Engineering company wide. Support Business Development. Accountable for project budgets and develop engineering service proposals directly with medical device clients. Provide consult to clients on regulated process and project improvements that increase effectiveness getting medical devices to market.
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Director, Systems EngineeringBaxter Jan 2002 - Jun 2006Deerfield, Illinois, UsEngineering functional leader responsible for leadership and coordination of more than 30 system engineering employees, specializing in the development of medical device electronics and software. Drive proficiency in engineering disciplines including requirements development and management, product safety/risk analysis, system design verification, system design validation, software validation, system integration and testing, CE/FDA compliance engineering and system architecture. Organizational resource management of the systems engineering organization, through hiring, training, and re-deploying of personnel. Accountable for the systems engineering strategic direction and project success criteria. Responsible and accountable for assigning appropriate resources, sourcing temporary resources, providing project estimates, assisting in technical solutions and technically reviewing design solutions. Drive process improvements and standard practices including development of system engineering process procedures, guidance and templates, development of corporate-wide systems architecture development procedure and new product development processes. -
Program/Project LeadBaxter Feb 2002 - Jan 2006Deerfield, Illinois, UsIn addition to directing System Engineering facilitated program management which included bringing a new PCA Syringe Pump to market. Responsible for the project schedule, re-budget ($24M), feature set, product requirements and the designs to meet them, in a project that needed re-vitalization and new leadership. Lead the multi-functional team of 40+ professionals through completion of design, implementation, and V&V and launch phases of project.Additional project leadership opportunities in feature add projects involving other Baxter infusion pumps. These projects required careful, but aggressive decisions and action through clearly defining and managing project scope, schedule, budget and coordination and management of technical risks. Visited medical buying groups, where product improvements were anticipated, and described project status and answered customer questions to support customer satisfaction and sales efforts.
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Systems Engineering ManagerBaxter Jan 1999 - Dec 2002Deerfield, Illinois, UsEngineering Functional leader responsible for the creation and leadership of the Systems Engineering function within the Infusion Systems business unit supporting approximately 150 technical resources. Built function through process development, training of existing resources and hiring of new engineers.
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Quality And Reliability Engineering ManagerBaxter Jan 1996 - Dec 1999Deerfield, Illinois, UsResponsible for product and process quality in the product development department as well as responsible for quality operations for facility that performs medical device manufacturing, product service and controlled substance distribution. Manage quality engineers that support product development and software development and direct management of quality for medical device manufacturing and service facility. Develop process improvement policies through quality manual and instituted quality system alignment with divisional requirements after acquisition. Facility achieved ISO certification, and participated in successful FDA inspections.
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Quality And Reliability EngineerBaxter Jan 1992 - Dec 1996Deerfield, Illinois, UsPerform product risk analysis, software and system quality analysis on medical device designs and embedded software. Review and approve product requirements, specifications, design documents, verification and validation plans and procedures. Develop process procedures that comply with regulations, including hazard analysis process assuring design safety. Perform internal and external process and product quality audits. Engineer responsible for multiple product line complaint evaluations, preventive and corrective action planning and implementation of product improvements. Participate in FDA inspections.
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Manufacturing Quality EngineerBaxter Nov 1987 - 1992Deerfield, Illinois, UsImplement process control charts and utilize capability analysis to improve processes in drug manufacturing plants. Perform Design of Experiments to improve automated manufacturing process, and to characterize critical control points. Perform software validations, develop process controls to meet drug GMP’s. Participated in FDA inspections. Supervise quality inspectors in aseptic manufacturing process production line.
Bob Barrett Skills
Bob Barrett Education Details
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Keller Graduate School Of Management Of Devry UniversityProject Management -
Southern Illinois University, CarbondaleElecrical Engineering Technology
Frequently Asked Questions about Bob Barrett
What company does Bob Barrett work for?
Bob Barrett works for Full Spectrum
What is Bob Barrett's role at the current company?
Bob Barrett's current role is Medical Device Systems Engineering Professional.
What is Bob Barrett's email address?
Bob Barrett's email address is ro****@****aim.com
What schools did Bob Barrett attend?
Bob Barrett attended Keller Graduate School Of Management Of Devry University, Southern Illinois University, Carbondale.
What skills is Bob Barrett known for?
Bob Barrett has skills like Fda, Quality System, Medical Devices, Validation, Cross Functional Team Leadership, V&v, Capa, Design Control, Testing, Iso 13485, Systems Engineering, Fmea.
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