R&D Engineer
Our client, a high-potential startup company, is seeking an R&D Engineer to support the product development of a cutting-edge device through design development, verification, clinical trials, validation, and regulatory approval.
This role offers the opportunity to join an exciting early-stage company with a dynamic team.
Key Responsibilities:
* Develop device specifications in line with user needs and Design Inputs, including innovative solutions.
* Provide technical and project leadership for R&D activities, ensuring quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability.
* 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.
* Select product materials, assembly methods, and define process settings, participating in sourcing, testing, and approving materials.
* Develop test methods for product evaluation and validation.
* Leverage external resources to achieve project goals, driving risk management for sub-assemblies under their responsibility.
Requirements:
* 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 is highly preferred.