Senior R&D Engineer Opportunity
Job Overview: We are seeking a highly skilled Senior R&D Engineer to join our team and contribute to the development of innovative medical devices.
Key Responsibilities:
* Manage and deliver R&D activities associated with the lifecycle management of medical devices.
* Oversee various aspects of the product's lifecycle, including material changes, process improvement, regulatory submissions, shelf-life studies, and responding to sales & marketing requests.
* Acquire in-depth knowledge of current products from a technical point of view: design, materials, performances, 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.
* Investigations on product complaints and analysis of returned devices.
* Support to CAPA and Non-Conformance process.
* Evaluation and scoping of process changes, material changes, vendor changes.
* Support to Labelling changes and implementation.
Requirements:
* A minimum of 5 years' experience in all stages of medical device design and development is required.
* Mechanical or biomedical engineering degree or equivalent is required.
* Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems is required.
* Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles is required.
What Awaits You:
* This is an opportunity to work with a ground-breaking biomedical operation.
* An opportunity to be part of a global market leader.
* A dynamic and inspiring working environment.
* Opportunities to work on challenging projects and assignments.
* Possibilities for further personal and professional development/education.
* Excellent benefits.