ABOUT THE ROLE Eakin R&D is now recruiting for an Electronics Hardware Engineer based in Coleraine, reporting to the Director of Product Respiratory.
As the Electronics Hardware Engineer you will design, develop, and test state-of-the-art electromedical devices for high-performance applications within anaesthesia and intensive care.
You will play a crucial role in the next phase of developing new and existing products in the Respiratory portfolio.
KEY ACTIVITIES Input to critical path design and development of new and existing electromedical devices.
Oversee repairs and servicing of electromedical devices.
Collaborate on customer complaints and implement corrective actions to resolve issues.
Maintain calibration schedules for testing equipment, ensuring accuracy and reliability.
Conduct analyses to identify root causes of failures and recommend preventive measures.
Apply finite element analysis techniques to assess product designs and performance.
Diagnose and resolve technical issues promptly and effectively.
Input with others to develop medical device labelling, user manuals, technical reports, and other documentation as needed.
Collaborate with suppliers and internal colleagues to ensure that product and process quality requirements are satisfied.
Collaborate on testing of incoming goods to verify compliance with specifications.
Ensure compliance with specifications for component parts used in production.
Coordinate and oversee external testing activities.
Participate in and prepare for internal and external audits to ensure compliance with quality standards.
Ensure adherence to ISO13485 design control processes and compliance requirements.
Maintain compliance with EU MDR 2017/745, EU MDD 93/42/EEC, ISO60601-1, and WEE regulations.
Ensure compliance with GS1 and UDI labelling requirements.
Provide customer support through field visits and technical assistance.
Conduct training sessions for staff members and cross-functional teams.
Assess and report on environmental impacts of products and processes.
Stay updated on industry standards, regulations, and technologies.
Promote and adhere to safety protocols in all activities.
Other To adhere to the companys Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
To be responsible for your own health and safety and that of your colleagues, in accordance with the companys Health and Safety policy.
To adhere to the companys Quality policy and Environmental policy.
To undertake other duties as may be reasonably required.
KEY SKILLS Essential Educated to degree level in electronics or mechatronics Previous experience working within an electronics development team Significant experience of hands-on electronics product development Previous experience in PCB design or PCB fault-finding and repair Capability in SolidWorks CAD Desirable Previous experience working with medical device electronics Prior experience of working within a QMS system when developing electronics.
Significant experience of testing and fault-finding electronics products including PCBs Knowledge of requirements in Standards ISO 13485, IEC 62304, ISO 14971, IEC 62366-1, IEC 60601-1 and IEC 61010-1 KEY WORKING RELATIONSHIPS Internal R&D Senior Management Commercial Production Quality Regulatory Procurement External Suppliers End users / Health Care Professionals Auditors ADDITIONAL INFORMATION Occasional travel, as and when required, to other Eakin Healthcare sites, external suppliers and to end users, e.g.
healthcare professionals.
Skills: Electronics critical path design electromedical devices corrective actions Root Cause Analysis ISO13485