Job Role: Senior R&D Engineer
About the Job
This is a dynamic opportunity to join our organization as a Senior R&D Engineer, contributing to the development of innovative medical devices. As a member of our team, you will play a key role in managing and delivering R&D activities associated with the lifecycle management of our products.
Responsibilities
* Manage various aspects of product lifecycle including material changes, process improvement, regulatory submissions, shelf-life studies, and responding to sales & marketing requests.
* Support product/process optimization projects in liaison with Supply Chain and Quality.
* Acquire an in-depth knowledge of current products from a technical point of view, including design, materials, performances, and manufacturing process.
* Support second supplier and/or technical transfer projects.
* Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
* Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
* Lead product Shelf-Life studies through Design Verification testing.
* Investigate product complaints and analyze returned devices.
* Support CAPA and Non-Conformance processes.
* Evaluate and scope process changes, material changes, vendor changes.
* Support labelling changes and implementation.
Requirements
To be successful in this role, you will need:
* A minimum of 5 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing).
* Mechanical or biomedical engineering degree or equivalent.
* Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments, including catheters, stents, delivery systems.
* Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
What We Offer
We offer a dynamic and inspiring working environment, opportunities to work on challenging projects and assignments, possibilities for further personal and professional development/education, and excellent benefits.