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- Develop specific electronic hardware design and development procedures to be used for the developmentof the electronic components of the product, as an integral part of the company's product developmentprocess.
- 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 electronicelements 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.
Senior Electronic Engineer - Ireland - Pale Blue Dot Recruitment
Description
Galway , Connaught , Ireland Software / Hardware
Our client, an exciting medical device start-up, based in Galway is hiring a Senior Electronic Engineer. The successful candidatewill provide technical supportto 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:
Job requirements
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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