Senior R&D Engineer
Our client a high potential medical device start-up is looking to hire a senior R&D Engineer 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. Reportying to the CTO the Senior R&D Engineer will work as part of the R&D team to design and develop a device in line with user needs, including generating creative solutions to problems
Role and responsibilities:
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 seven (7) 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
Class III medical product development experience involving clinical trials 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.
Working knowledge of 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
James Cassidy | Tel: +353 (0) 1 5079250