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James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
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Details

Senior R&D Engineer


Reference:JCAO2211 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Senior Research and Development Engineer

Our client a high potential and well funded start up are currently seeking a Senior R&D Engineer to join their team. Reporting to Director of R&D Senior R&D Engineer will support the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company.


Role/Responsibilities

  • Responsible for developing device specifications, in line with user needs and Design Inputs, including innovative solutions. Provide technical and project leadership for R&D activities
  • Design sub assemblies and finished devices, including design selection, material selection and assembly method selection. Create detailed component and finished device assembly drawings/specifications
  • Build and test prototypes; analyse test data and interpret to identify optimal solution
  • Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.
  • Develop test methods for product evaluation and validation. Develop and execute test method validations.
  • Leverage and liaise with external resources to achieve project goals
  • Drives risk management for sub-assemblies under their responsibility and drives a system level risk based design approach.
  • Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability
  • Ensure interactions with colleagues/stakeholders fully reflects the company values:
  • One Team: working together to ensure the whole is greater than the sum of the parts
  • Personal Ownership: deliver on commitments
  • Open Communication: Honest open-minded communication
  • Fun: celebrate the successes
  • Continuous Learning: at an individual and company level
  • Solution Orientated: Identify problems but focus your energy on solutions
  • Quality Focused: patient safety comes first
Skills/Experience
  • B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines
  • Minimumfive years of related experience in medical device mechanical design/product development
  • Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles. Prior experience in cardiovascular/nitinol/delivery system medical products highly preferred
  • Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
  • Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.
  • Experience interfacing with clinicians and reducing feedback to device concept
  • Excellent organizational and time management skills
  • Experience designing with Nitinol for Class III implant devices is a significant advantage



For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322





The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.