R&D Engineer

2 weeks ago

Portlaoise, Laois, Ireland Life Science Recruitment Full time
R&D Engineer

Our client, a high-potential startup company, is looking to hire an R&D Engineer who will support the product development of a cutting-edge device through design development, verification, clinical trials, validation, and regulatory approval. Reporting to the Director of R&D, this role offers the opportunity to join an exciting early-stage company.

Role/Responsibilities:

- 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.
- Design sub-assemblies and finished devices, including design selection, material selection, and assembly method selection. Create detailed component and finished device assembly drawings/specifications.
- Build and test prototypes; analyze test data and interpret to identify optimal solutions.
- Identify and select product materials, assembly methods, and define process settings. Participate in sourcing, testing, and approving materials.
- Develop test methods for product evaluation and validation. Develop and execute test method validations.
- Leverage and liaise with external resources to achieve project goals.
- Drive risk management for sub-assemblies under their responsibility and drive a system-level risk-based design approach.
- Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability.

Education and Experience

- B.S. or Master's degree in mechanical engineering, biomedical engineering, or related disciplines.
- Minimum three 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.
- 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 concepts.
- Excellent organizational and time management skills.
- Experience designing with Nitinol for Class III implant devices is a significant advantage.

For further information, please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence at 0860204322.

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