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Gaillimh

    Senior Electronic Engineer - Galway, Ireland - Pale Blue Dot® Recruitment

    Pale Blue Dot® Recruitment
    Pale Blue Dot® Recruitment Galway, Ireland

    1 week ago

    Pale Blue Dot® Recruitment background
    Full time
    Description

    Our client, an exciting medical device start-up, based in Galway is hiring a Senior Electronic Engineer. The successful candidate will provide technical support to the product development team, liaising with external partners in the development of a novel medical technology.


    Responsibilities include but are not limited to the following:

    • Develop specific electronic hardware design and development procedures to be used for the development of the electronic components of the product, as an integral part of the company's product development process.
    • Provide input and review to the company's Quality Management System for the electronic aspects of
      product development.
    • Ensure all hardware development is in compliance with IEC , IEC , related standards, and
      FDA guidance.
    • Review and assess for inclusion any other related standards for the electronic hardware and software
      components required for CE marking or FDA 510(k) applications.
    • Provide input to the product development schedule, milestones, and task/work packages for the electronic elements of the product development.
    • Manage the electronic development schedule to align with the overall product development schedule – with input from third-party development partners where applicable.
    • Lead the development of the following Hardware(HW) documents:
      - HW Requirements; HW architecture/specification/design; Schematics, PCB layouts, wiring diagrams, etc. ; HW verification protocols and reports; HW Design & Use FMEAs; HW risk management; Requirement/spec/test traceability matrix; Design reviews at key stages of the project
    • Aid (guidance, input, & review) in the development of the following documents:
      - User and product requirement documents ; design input/output specifications ; System/product risk management ; Design verification & validation to identified hardware-related standards.
    • Liaise with, and provide technical oversight of, third-party development partners in the design, building, and testing of the electronic systems.
    • Develop expertise in the realms of ultrasonic transducer design, control circuits, electronic hardware & software testing.
    • Aid in the transfer of PCB Assemblies and other hardware components into manufacture.
    • Provide mentoring and support of more junior engineering staff.
    • Provide general support and input to the overall product development process and tasks.
    • Where required attend meetings with sub-contractors on an as-needed basis, in-person or online.
    • To perform such other functions from time to time as requested by the Company.
    • Level 8 degree or higher in Electronic Engineering.
    • Strong knowledge of analogue circuit design and test, including power electronics.
    • Knowledge of digital circuit design, including programmable logic.
    • Experience in Design For Manufacture for high-volume markets.
    • Use of schematic capture and PCB layout tools (Altium preferred).
    • Knowledge of electrical safety principles (IEC
    • Knowledge of EMC principles (IEC
    • Working knowledge of medical device regulations and design control principles.
    • Knowledge of IEC 62304 for software development would be desirable, but not essential.

    Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.

    Pale Blue Dot Recruitment - The Resource for the MedTech Workforce

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