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Experienced engineer and manager of medical device products and systems. Responsible for all aspects of new product development from requirements generation through product launch and support. Medical device experience: Radiation oncology, Ultrasound wound healing, Left ventricular assist device, RF feeding tube guidance system, Electroporation oncology.
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Senior Principal Systems EngineerNextern Apr 2021 - PresentWhite Bear Lake, Mn, Us* Responsible for creating and building internal requirement sets and assisting the customer in developing user requirements.* Support developing the risk management plan and report. * Assist in creation, review, and documentation of risk analyses.* May assist in development and review of a Hazard Analysis.* Accountable for ensuring product verification and validation and ensuring traceability is met for all requirements.* Coordinate and facilitate interdisciplinary technical discussions within project teams.* Responsible for coordinating and documenting system level analysis including system modeling, algorithm development, simulations, and system architecture.* Lead in the development of streamlined processes and procedures for development of complex systems.* Serve as the primary technical contact for customers on projects.* Provide technical leadership to the project team across multiple disciplines.* Responsible for the technical project scope and effort.* Develop and coordinate engineering labor estimates for new projects and changes in scope.* Serve as a mentor to junior engineering staff.* Lead the efforts to identify and implement technology re-use.* Coordinate technical design reviews during product realization.* Assist in identifying and evaluating technical talent.* Work with Business Unit Manager to identify technical training and tools for the engineering teams to enhance the development processes.* Work to ensure Nextern development processes deliver artifacts that meet the requirements of the relevant standards and regulatory agencies. * Actively pursue identification and protection of Nextern intellectual property. -
Senior Principal Systems EngineerMinnetronix, Inc. Mar 2019 - Mar 2021St. Paul, Mn, UsResponsible for maintaining and enhancing the technical excellence of Minnetronix research and development work, including new product development, product sustaining, and manufacturing support. Act as a technical leader on development programs, lead all aspects of the technical execution of projects, assume responsibility for technical project deliverables, and work with Program Managers to assure successful project outcomes. Responsible for leading efforts to build and support the technical excellence of Minnetronix technology and development methods and processes. Work with engineering management and teams to ensure appropriate technological expertise and intellectual property is developed or acquired. Detailed responsibilities of the Principal Systems Engineer, with the addition of:* Define and design core components for re-use in products* Represent and explain core Minnetronix technologies, processes, and capabilities within the medical device community -
Principal Systems EngineerMinnetronix, Inc. Apr 2016 - Feb 2019St. Paul, Mn, UsDetailed responsibilities include:* Fulfill technical leadership role on major development projects, assuming responsibility for successful completion of all technical project deliverables* Work with Program Managers to identify resource needs for projects and direct technical execution of project work* Lead technical reviews* Participate in process improvement activities within the Engineering department* Investigate new technologies and opportunities for innovation, leading to increased value to customers* Identify opportunities for intellectual property development, both internally and for clients* Work with engineering managers to identify and obtain necessary technical expertise, training, and resources to support a diverse range of new product development and support efforts* Monitor the technical regulatory climate to ensure design solutions will meet required worldwide regulations* Contribute to new product development proposals and participate in client and potential client meetings -
Principal Systems EngineerLogic Pd Jun 2015 - Mar 2016Eden Prairie, Mn, UsDetailed responsibilities include:* Provide overall technical leadership on a wide range of projects* Represent Logic PD’s technical expertise and capabilities to potential customersduring business development activities* Instruct, direct, and check the work of other engineers as a key engineering leader* Define user needs, use cases, customer needs and product requirements inconjunction with customers and other engineering disciplines* Translate product requirements into implementable architectures and designspecifications* Plan and lead integration and verification testing* Lead and participate in risk and hazard analyses and design reviews* Perform or direct design analysis on components and/or assemblies. Ensure designsare cost effective, manufacturable, testable, serviceable and reliable* Ensure engineering projects are completed within budgetary and schedulingguidelines in conjunction with the project manager* Identify and communicate issues along with suitable recovery plans to keep projectson schedule* Ensure the final design meets quality and reliability goals* Analyze business requirements and document a suitable technical approach forinternal and external (customer) proposals* Actively engage with the external technical community through writings or talks topromote Logic PD’s business development -
Manager, Systems And Reliability EngineeringAccuray Jan 2007 - Nov 2014Madison, Wi, UsResponsible for planning and execution of the systems engineering programs, including overall system development and conformance to the applicable safety and regulatory requirements.Primary responsibilities include:* Full HR-related tasks to grow and manage the team, including recruitment, hiring, performance review, and discipline/termination activities for both full-time and contingent staff* Complete resource allocation management, including task estimation, project assignments, milestone setting and tracking, tool identification, and budget coordination* Ensure full compliance to internal process documentation and execute continuous improvement by verification of these processes to regulatory and quality standards* Act as a product technical leader through architecture recommendations and assisting design engineers with decision making and troubleshooting activities* Work with other leaders to meet department and company goals to achieve maximum customer satisfaction with products and servicesDisciplines managed:* Systems Engineering* Reliability Engineering* Regulatory Standards Compliance Engineering* Requirements Engineering* Engineering Medical PhysicsThe engineering team included up to 13 full-time staff and 7 contingent employees at one time. -
Systems EngineerTomotherapy Mar 2004 - Dec 2006Madison, Wisconsin, UsResponsible for the design and development of not only the overall radiation delivery system of the product, but also the sub-systems which comprise it. These sub-systems include:* Embedded control systems* Electrical power conditioning and distribution* High Voltage pulsed power* S-band microwave power generation and transmission* High energy X-ray generation and collimation* Radiation detection and monitoring* Data acquisition and signal processing* Closed-loop water system for temperature controlPrimary responsibilities include:* Generating and documenting system-level requirements* Assisting in system-level test generation and execution* Researching sub-system function and design* Generating sub-system procurement/performance specifications* Generating and executing sub-system qualification tests* Reviewing component designs and fabrication* Reviewing internal and external user documentation* Expert-level troubleshooting to resolve internal and external user issues with the radiation delivery system. -
Production Engineering TechnicianTomotherapy Oct 2002 - Feb 2004Madison, Wisconsin, Us* Participate in new product development projects to represent manufacturing requirements and goals* Interface with R&D personnel to facilitate the transfer of product designs into manufacturing* Develop requirements for received materials, in-process product, and final product inspection/test through interaction with Design Engineering personnel and suppliers* Assist in troubleshooting and resolving issues at customer locations* Participate in final assembly qualification and testing* Develop manufacturing instructions for assembly personnel in regulated environment* Provide or assist in training of manufacturing and service personnel* Assist in the management of product changes to ensure correct implementation -
Manufacturing AssemblerTomotherapy Sep 2001 - Sep 2002Madison, Wisconsin, Us* Assembly and manufacture of product, in accordance with quality system requirements, manufacturing processes, and manufacturing instructions* Perform or assist in received materials, in-process product, and final product inspection/test* Participate in development and review of manufacturing procedures and instructions as well as bills of material
Jonathan Mcintosh Skills
Jonathan Mcintosh Education Details
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University Of Wisconsin-MadisonBachelor Of Science - Electrical Engineering
Frequently Asked Questions about Jonathan Mcintosh
What company does Jonathan Mcintosh work for?
Jonathan Mcintosh works for Nextern
What is Jonathan Mcintosh's role at the current company?
Jonathan Mcintosh's current role is Senior Principal Systems Engineer at Nextern.
What is Jonathan Mcintosh's email address?
Jonathan Mcintosh's email address is jm****@****nix.com
What is Jonathan Mcintosh's direct phone number?
Jonathan Mcintosh's direct phone number is +195294*****
What schools did Jonathan Mcintosh attend?
Jonathan Mcintosh attended University Of Wisconsin-Madison.
What skills is Jonathan Mcintosh known for?
Jonathan Mcintosh has skills like Systems Engineering, Medical Devices, Reliability Engineering, Design Control, R&d, Testing, Iso 13485, Fda, Engineering Management, Project Management, Requirements Management, Embedded Systems.
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