Job Title: Principal R&D Engineer
This role is a key position in the product development team, responsible for leading the design and development of cutting-edge medical devices. The successful candidate will work closely with internal and external stakeholders to drive innovation and deliver high-quality products.
Key Responsibilities:
* Lead design and development at a system level, generating detailed specifications and reviewing sub-systems.
* Design systems, including robust design selection, material selection, and assembly method selection.
* Manage the sourcing, building, and testing of systems, ensuring comprehensive data analysis drives optimal device design.
* Define and manage comprehensive test suites to fully understand device design, risk, and verify/validate it in line with device specifications.
* Proactively manage risks throughout the product lifecycle to drive risk management at an overall system level.
* Ensure good Design Control practices are followed, generating a complete audit-ready Design History File.
* Ensure quality in product design for durability, usability, reliability, functionality, marketability, and manufacturability.
* Lead technical discussions with multiple stakeholders, adapting and supporting materials to ensure clear understanding.
* Proactively ensure Company Goals are achieved.
Required Skills and Qualifications:
* B.S. or master's degree in mechanical engineering, biomedical engineering, or related disciplines.
* Eight years of related experience in medical device mechanical design/product development.
* Cardiovascular medical product development experience preferred.
* Comprehensive ability to assess in vitro and in vivo properties of devices/device components.
* Detailed working knowledge of FDA, GMP, QSR, and ISO 13485 requirements.
* Experience interfacing with clinicians and reducing feedback to appropriate designs.
* Excellent organizational and time management skills.
Benefits:
The company offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
Others:
For further information, please contact James Cassidy or call 086 0204322.