Our client, a highly disruptive medical device technology company is developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in times of acute heart failure or patients undergoing high-risk coronary procedures. Their objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device.
As the Senior R&D Engineer - Control System, you will be part of our client's R&D team. Your key responsibility as the Senior R&D Engineer is the design of an electromechanical driver control system, which actuates and controls our client's pump heads. This driver console must become an intuitive interface between the clinical user and the driving mechanism of our client's operating system. You will work closely with his/her counterparts, in test and product development engineering as well as third-party development partners. You will share the responsibility of realizing the full potential of our client's technology. You will have hands-on experience in the design of electromechanical machinery for the medical devices industry and can work from either the company’s office in Galway or Nijmegen and be able to travel occasionally.
Translation of pump head functional requirements into control system output requirements and a detailed design specification.
Ownership and oversight of the electro-mechanical design of the control system (console, actuator & pump elements).
Continuous calibration of the driver requirements with the stakeholders
Ability to achieve the right balance between technical functionality and user-friendliness.
Be the project leader from developing initial prototypes, through FIH standard systems and on to series manufacturing at our client's vendor(s).
Conduct & support risk management activities related to development i.e. PHA, DFMEA, etc.
Conduct or manage the testing of devices and components for feasibility, verification & validation, or root cause investigations.
Integrate the learnings from user/Control System interactions to improve the usability of the device.
Document development work in laboratory notebooks and technical reports. Summarise information and present key findings and conclusions.
Improve the efficiency of cross-functional workstreams in the development of the device.
Coordinate with colleagues and suppliers to ensure deliverables and milestones are achieved.
Provide input to relevant QMS procedures in development, risk management, and instructions for use; also to usability, pre-clinical, DV&V, and clinical protocols.
Draft invention disclosures and address queries from patent agents.
Responsibility to specify, source, test, and qualify the appropriate electronic, gas, and mechanical elements of the Control System (e.g. HMI consoles, sensors, linear actuators, pneumatics, PLCs, sensors, actuators).
Minimum 5 years of industrial experience in developing electromechanical systems and interfaces for medical devices.
Educated to NFQ level 9 or above in a relevant engineering discipline (mechatronics, electrical or mechanical). NFQ level 7/8 with additional, relevant experience also considered.
Knowledge of IEC 60601-1 and the basic safety and essential performance requirements of medical electrical equipment.
Conduct or manage the testing of software and hardware elements for feasibility, verification & validation, or root cause investigations. Basic knowledge of the V-model is preferred.
Ability to analyze and troubleshoot the machine elements of the Control System.
Programming skills in real-time control environments. Experience with PLC design is essential.
Experience with applying Human Factors Engineering principles in the development of interfaces for electromechanical medical devices.
For more information or a confidential discussion about this role please contact Michelle McInerney
091 706 717