Senior R&D Engineer
Our client a medical device start are currently seeking a Senior R&D team to join their team. Reporting to R&D Director the Senior R&D Engineer will support the product development of a cutting edge device through design development, verification, clinical trials, validation and regulatory approval.
Role/Responsibilities
1. 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
2. Design sub assemblies and finished devices, including design selection, material selection and assembly method selection. Create detailed component and finished device assembly drawings/specifications
3. Build and test prototypes; analyse test data and interpret to identify optimal solution
4. Identify and select product materials, assembly methods and define process settings. Participate in sourcing, testing and approving materials.
5. Develop test methods for product evaluation and validation. Develop and execute test method validations.
6. Leverage and liaise with external resources to achieve project goals
7. Drives risk management for sub-assemblies under their responsibility and drives a system level risk based design approach.
8. Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability
Skills/Experience
9. B.S. or master degree in mechanical engineering, biomedical engineering, or related disciplines
10. Five years of related experience in medical device mechanical design/product development
11. 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
12. Strong capability of assessing in vitro and in vivo properties of device/device components including knowledge of the implant/tissue interface and challenges.
13. Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements.
14. Experience interfacing with clinicians and reducing feedback to device concept
15. Excellent organizational and time management skills
For further information please contact James Cassidy or call in confidence 086 0204322