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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Principal R&D Engineer


Reference:JCAO20212 Location: Dublin Greater
Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Principal Engineer


Principal R&D Engineer


Our client a high potential start up is currently seeking a Principal R&D Engineer to join their team. Reporting to the head of R&D the Principal R&D Engineer will take the lead technical role in the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval. The technology being developed will address a key unmet clinical need and the Principal R&D Engineer will be a key member of the team and help drive the development of the technology.


Role/Responsibilities

  • Lead design and development at a system level, generation of detailed specifications, including review and approval of sub-systems.
  • Design systems, including robust design selection, material selection and assembly method selection. Detailing finished device specifications to ensure a robust and right first time device.
  • Manage the sourcing, building and testing of systems; ensuring detailed and comprehensive data analysis to drive the device design in the optimal direction
  • Define and manage the execution of comprehensive test suites to fully understand device design, risk and verify & validate it in line with device specifications.
  • Proactive management of risks throughout the product lifecycle to drive risk management at an overall system level, ensuring risk based design.
  • Ensure the device development follows good Design Control practices, in line with ISO13485. Generating a complete, audit ready, Design History File.
  • Ensure Quality in the product’s design for durability, usability, reliability, functionality, marketability and manufacturability
  • Lead technical discussions with multiple internal and external stakeholders, adapting s and supporting material to suit the discussion to ensure clear understanding of all parties.
  • Proactively ensure Company Goals are achieved and act an example to others in embodying the Company Values

Education and Experience

  • B.S. or Masters degree in mechanical engineering, biomedical engineering, or related disciplines
  • 10 years of related experience in medical device mechanical design/product development
  • Cardiovascular medical product development experience preferred
  • Comprehensive ability to assess in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
  • Detailed working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
  • Experience interfacing with clinicians and reducing feedback to appropriate designs
  • Experience with implantable cardiovascular devices and / or steerable catheter systems would be a distinct advantage
  • Excellent organizational and time management skills




For further information please contact James Cassidy [email protected] or call 0860204322