Senior R&D Engineer


Category: Manufacturing Technician, Pharmaceutical / Science
Job Type: Full Time

Posted on:
Last Updated:

Kelly Services is looking to recruit a senior R&D Engineer for a Dublin based Medical Device Company who will support the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company.

Role and responsibilities:

  • Working as a senior part of the R&D team to design and develop a novel transcatheter heart repair device in line with user needs, including generating creative solutions to problems.
  • Contribute to the company’s existing technology and intellectual property portfolio through innovation and invention.
  • Provide technical and project leadership for R&D activities.
  • Liaise where necessary with Physicians to understand and validate the specific user requirements.
  • Identify and manage of key risks throughout the product life cycle.
  • Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.Build and test prototypes; analyse test data and interpret to identify optimal solution.
  • Responsible for developing device specifications, in line with user needs and Design Inputs. Create detailed component and finished device assembly drawings/specifications.
  • Develop test methods for product evaluation and validation. Develop and execute test method validations.
  • Support the implementation of design to the manufacturing operation through well defined, robust processes.
  • Delivery of technical/ product training to physicians.
  • Leverage and liaise with external resources to achieve project goals.
  • Ensure quality in the product’s design for durability, usability, reliability, functionality, marketability, and manufacturability.
  • Reports directly to the CTO.

Requirements:

  • B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines.
  • Minimum of five (5) 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.
  • Familiar with problem solving techniques and methodologies with broad biomedical materials and processing knowledge.
  • Implant medical product development experience involving clinical trials.
  • 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.
  • Availability to travel is required.

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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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