Senior R&D Engineer
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
- Provide technical and project leadership for R&D activities
- Contribute to the company's existing technology and intellectual property portfolio through innovation and invention
- Liaise where necessary with Physicians to understand and validate the specific user requirements
- Identify and manage of key risks throughout the product lifecycle
- 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, rocust 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.
- 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.