Our client a medical device start-up are looking to hire an 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. Reporting to the CTO the R&D Engineer will work on R&D team to design and develop a device in line with user needs, including generating creative solutions to problems. This position offers the opportunity to join an exciting early stage company.
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.
Generate technical documentation for the Product Design History File and Device Master Records
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 four (4) 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