We are partnering exclusively with an innovative medical device start-up based in Galway. They are expanding and looking for a Senior Electronic Engineer to lead the design and development of their next-generation technology.
What You’ll Do
- Design & Develop: Create and implement electronic hardware systems as part of the overall product development process.
- Ensure Compliance: Ensure all designs meet key regulatory standards (IEC 60601-1, IEC 60601-1-2, FDA guidelines).
- Own Documentation: Lead the creation of hardware specs, schematics, risk analyses (FMEA), test protocols, and traceability matrices.
- Drive Process: Develop and manage development schedules and milestones for the electronics workstream.
- Collaborate: Work closely with third-party partners, internal teams, and manufacturing to deliver robust and compliant designs.
- Support Quality: Contribute to the Quality Management System and regulatory submissions (CE marking, FDA 510(k)).
- Innovate: Build expertise in ultrasonic transducers, control systems, and electronic testing.
What You’ll Need
- Degree (Level 8 or higher) in Electronic Engineering.
- Strong skills in analog and digital circuit design, including power electronics and programmable logic.
- Experience with schematic capture & PCB layout tools (Altium preferred).
- Familiarity with design for manufacture, particularly for high-volume production.
- Working knowledge of IEC 60601 standards and EMC principles.
- Understanding of medical device regulations and design control.
- Ideally knowledge of IEC 62304 software lifecycle standard.
For a confidential discussion and more information on the role, please contact Amy Newell
amy.newell@collinsmcnicholas.ie
091-706718