Job title: Senior R&D Engineer – Control system
Location: Parkmore, Galway


Company:
My client are a medical device company 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 (cardiogenic shock) or patients undergoing high-risk coronary procedures (high-risk PCI). Their objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device. Founded in 2018 as a Radboud UMC spin-off. They are an enthusiastic team with diverse backgrounds and expertise located in the Netherlands and in Galway Ireland.


Job Description:

The key responsibility of the Senior R&D Engineer - Control System is the design of an electromechanical driver control system (“Control System”), which actuates and controls the pump head. This driver console must become an intuitive interface between the clinical user and the driving mechanism of the device.

The Senior R&D Engineer - Control System will work closely with his/her counterparts, in test and product development engineering as well as third party development partners. As a team, they are responsible for matching the pVAD system technical requirements and interface design.



Responsibilities:
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 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 vendor(s).
- Conduct & support risk management activities related to development i.e. PHA, DFMEA etc.
- Conduct or manage 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, instructions for use; also to usability, pre-clinical, DV&V and clinical protocols.


Required Qualifications:
- 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 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 testing of software and hardware elements for feasibility, verification & validation or root cause investigations. Basic knowledge of the V-model is preferred.
- Ability to analyse 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.


Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie