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 and work under the supervision of the Director of R&D.
Role/Responsibilities:
* Develop 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:
* Bachelor'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.