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Emtech Recruitment: Emerging Technologies Recruitment Specialists
Senior Electronic Design Engineer with experience in design for 510(k), IEC 60601-1 & IEC 60601-1-2 required by high-growth medical devices company 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:
1. Degree in Electronic Engineering / similar
2. 6+ years experience in an Electronic design role
3. Experience in detailed design - including schematic capture, PCB design, BOM generation
4. Experience in design for 510(k), IEC 60601-1 and IEC 60601-1-2
5. Proficient in electronic circuit design – Analog and Digital
6. Experience using development tools such as OrCAD Capture and PCB Designer
7. Knowledge of Microcontroller interfacing such as SPI, I2C, UART, ADCs
8. Thorough understanding of the hardware deliverables required for CE marking and/or FDA 510(k) submissions
RESPONSIBILITIES:
1. Design - including schematic capture, PCB design, BOM generation - in accordance with CE & FDA regulations
2. Collaborate as a member of cross-functional project teams in developing products from concept through to commercialization
3. Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance
4. Conduct use and design risk assessment, implementing controls or mitigations to reduce risk levels
5. Conduct and record proof of principle testing of prototypes to confirm feasibility of ideas and concepts
6. Engage with clinicians and product users in their clinical setting to elicit user needs
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology, Engineering, and Design
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Appliances, Electrical, and Electronics Manufacturing
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