Our client, located here in Galway, is a high growth disruptive 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 or patients undergoing high-risk coronary procedures. Our objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device.
The Senior R&D Engineer - Catheter System will be an experienced medical device engineer with intimate knowledge of medical device development for interventional cardiology. The key responsibility will be the development of the company’s catheter, including the development of the design, the associated manufacturing and assembly processes, as well as the selection and management of suppliers of catheter components. The Senior R&D Engineer will work closely with his/her counterparts responsible for device characterization, other development functions, as well as quality affairs and marketing functions. The Senior R&D Engineer will share the responsibility of realizing the our clients full potential.
Essential Job Responsibilities:
Design the Catheter System from user and expert inputs applying materials science and engineering first principles. Produce working prototypes of the Catheter System appropriate to the particular phase of development.
Develop assembly and manufacturing processes for the company’s catheter.
Anticipate risks and challenges; proactively ensure availability of adequate mitigation plans.
Development of DFMEA and PFMEA or similar risk management tools.
Manage relationships with third party development and manufacturing vendors.
Coordinate with colleagues and suppliers to ensure deliverables and milestones are achieved.
Conduct or manage testing of devices and components for feasibility, verification & validation or root cause investigations. Basic knowledge of the V-model is preferred.
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.
Required Qualifications & Characteristics:
Responsibility to specify, source, test and qualify the geometry and materials of the Catheter System.
Self-directed engineer with entrepreneurial drive with detailed understanding of interventional cardiology device requirements, preferably structural heart applications.
Minimum 5 years industrial experience in developing reinforced catheter and balloon systems for medical devices.
Educated to NFQ level 9 or above in a relevant engineering discipline (Polymers, Mechanical, Materials Science or Biomedical). NFQ level 7/8 with additional, relevant experience also considered.
Expert in materials selection and processing methods for thin plastic film components and membranes, balloons, single and multilumen tubing, reinforced braided/plastic composite tubes.
Experience with materials selection and processing methods for solvent and adhesive bonds, insert and overmoulding techniques.
Have an established vendor network relevant to the device type.
Experience with developing tests necessary to measure the performance of Catheter Systems in development, especially for novel devices where established techniques or international standards may not yet exist.
Working knowledge of data interrogation, DOE and applicable statistics.
Ability to navigate uncertainties, queries, opinions and requests and maintain
For more information on this role and a confidential discussion on the organisation please contact Chris O Toole