Title: R&D Engineer

Reports to: R&D Manager/Director

About CardiacBooster:

CardiacBooster is 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 cardiogenic shock and acute heart failure. Our objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device.

We are an enthusiastic team with diverse backgrounds and expertise, located in Galway, Ireland, and Nijmegen, Netherlands. CardiacBooster is an equal opportunity employer.

Job Description:

The R&D Engineer at Cardiacbooster will be an experienced medical device engineer with a strong knowledge of medical device development for interventional cardiology or structural heart. You will work within a dynamic R&D team tackling challenging engineering problems and generating novel solutions. The role will be hands on and include testing and test method development that will drive design optimisation. You should have hands-on knowledge and experience in the development and maintenance of test platforms for validation and verification. You will also be required to ensure that design for manufacture considerations are taken into account. The 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. He/She will share the responsibility of realizing CardiacBooster’s full potential. The successful candidate will have entrepreneurial spirit, the required persistence to succeed in a start-up environment, and the ability to work in a self-directed manner with minimal direction and supervision. He/She will have hands-on knowledge and experience in the development of cardiovascular devices. The R&D Engineer, will be a team player and have excellent communication skills.

The successful candidate will need a minimum of three years of medical device development experience, and have a either a primary or Master’s Degree in a relevant engineering discipline such as polymer, mechanical or biomedical engineering, or equivalent experience. This role will work from the company’s office in Ireland, and be in a position to travel occasionally.

Key Responsibilities

  • Your key responsibility is to measure and quantify the physical characteristics of the device by experimental design along with your R&D counterparts.
  • Your knowledge of solid and fluid mechanics, and other areas of physics should translate into hardware and software implementations of test platforms and their validation, including test protocols and data analysis tools.
  • You will work closely with your counterparts responsible for designing and manufacturing the pVAD device suggesting design improvements based on experimental results
  • Develop new test methods in partnership with device and scientific SMEs. Develop test capabilities, processes and protocols to support the development, verification, and validation of the company’s catheter device.
  • Document test method procedures and keep them updated in line with changes to standards.
  • Develop, design, document and perform test method validations.
  • Keep informed of new test standards, techniques or equipment and evaluate their impact on future orhistorical test data.
  • Good communication with peers and management in the continuous feedback loop between devicedesign and validation testing. Present updates and summaries of test data using statistical techniques where necessary.
  • Perform demonstrations of device operation for visiting customers, new starters, executives or investors.
  • Develop assembly and manufacturing processes for the company’s pVAD catheter
  • Participate in the development of DFMEA and PFMEA or similar risk management tools
  • Contribute to IP generation to protect novel developments and findings
  • Interact with third party development and manufacturing vendors

    Skills, Qualifications & Experience
  • The successful candidate will have a minimum of 3 years of medical device development experience, and have either a Master’s or primary Degree in a relevant engineering/scientific discipline such as applied physics, mechanical engineering, biomedical engineering, or equivalent experience.
  • Master’s or primary Degree in a relevant engineering discipline, or equivalent experience
  • Self-directed engineer with entrepreneurial drive
  • Experience in:
    – Use of statistical analysis techniques & DOE
    – Development of cardiovascular or equivalent devices, preferably catheter delivery systems
    – Functional and mechanical test method development.
    – Shaft joint design and process development
    – Intimate understanding of interventional cardiology device requirements, preferably structural heart applications .
  • Excellent communication skills in English and preferably one other European language
  • Ability to source, evaluate and manage suppliers of equipment, calibration services and sub-contracttesting.
  • Experience with change control and ability to process changes efficiently.
  • Experience working to regulatory requirements of 21CFR820, MDR and ISO13485.
  • Experience using 3D CAD modelling software (SolidWorks preferred).
  • Proficient in the use of office software packages (e.g., Microsoft Outlook, Word, Excel, PowerPoint etc.).

    Additional Desirable Experience or Qualifications in:
  • Polymer and reinforced composite Polymer Shaft design
  • Design for Manufacture methodologies
  • Understanding of sterilisation and biocompatibility testing of medical devices

  • Please submit your application, including resume, to hr@cardiacbooster.com

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel as classified.
categories: R&D
locations: Ireland

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