Our client a start up here in Galway are looking to hire a Senior Electronic Engineer as they grow their team.
Senior Electronic Engineer
The Role:
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 60601-1, IEC 60601-1-2, 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.
Responsibilities:
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 if applicable.
Lead the development of the following hardware documents:
Hardware Requirements
Hardware architecture/specification/design
Schematics, PCB layouts, wiring diagrams, etc.
Hardware verification protocols and reports
Hardware Design & Use FMEAs
Hardware 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, and 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.
Requirements
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 60601-1).
Knowledge of EMC principles (IEC 60601-1-2).
Working knowledge of medical device regulations and design control principles.
Knowledge of IEC 62304 for software development would be desirable, but not essential.
For more information or a confidential discussion about this role please contact Michelle McInerney
michelle.mcinerney@collinsmcnicholas.ie
091 706 717