R&D Engineer

R&D Engineer – Medical Devices 
(Galway)

For more details about this role get in touch – Contact Gary Keane
Email – [email protected]
Call – 086-1030418

Job Scope:

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).
Console experience and systems experience are required.
 

• 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 CardiacBooster’s 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.
• Draft invention disclosures and address queries from patent agents.

Required Qualifications & Characteristics:

• e, 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 1-5 years industrial experience in developing electromechanical systems and interfaces for medical devices.
• Educated to NFQ level 8 or above in a relevant engineering discipline 
• 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.
• Working knowledge of data interrogation and applicable statistics.
• Ability to navigate uncertainties, queries, opinions and requests and maintain focus on higher priority work communicating at a level of detail appropriate to the intended audience.
• Ability to negotiate agreement on path forward, develop a work-breakdown, execute a plan and provide updates on progress.
• Working knowledge of ISO13485, ISO14971, MDR, and relevant FDA guidances.
• Experience with 3D CAD design (SolidWorks) is preferred.
• Excellent communication skills in English and preferably one other European language
• Knowledge of the patent process is an advantage.

For more details about this role get in touch – Contact Gary Keane
Email – [email protected]
Call – 086-1030418

INDTRAC