Principal Electronic Design Engineer with experience in design for IEC 60601-1 & IEC 60601-1-2 required by high-growth medical devices company in Galway.

From it’s headquarters in Galway, my client designs highly sophisticated life-saving medical devices. Due to expansion in global markets, they are growing their design team yet again.

Collaborating with a cross-functional team, you will conduct product design and development in accordance with CE & FDA regulations for medical device design and manufacture for global markets.

REQUIREMENTS:

• Degree in Electronic Engineering / similar
• 9+ years experience in an Electronic design role
• Experience in detailed design – including schematic capture, PCB design, BOM generation
• Experience in design for IEC 60601-1 and IEC 60601-1-2
• Proficient in electronic circuit design – Analog and Digital
• Experience using development tools such as OrCAD Capture and PCB Designer
• Knowledge of Microcontroller interfacing such as SPI, I2C, UART, ADCs etc.
• Understanding of the hardware deliverables required for CE marking and FDA 

RESPONSIBILITIES:

• Design – including schematic capture, PCB design, BOM generation – in accordance with CE & FDA regulations
• Collaborate as a member of cross-functional project teams in developing products from concept through to commercialization
• Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance
• Conduct use and design risk assessment, implementing controls or mitigations to reduce risk levels
• Conduct and record proof of principle testing of prototypes to confirm feasibility of ideas and concepts
• Engage with clinicians and product users in their clinical setting to elicit user needs