Job Description
As a key member of our research and development team, you will play a critical role in managing and delivering R&D activities associated with the lifecycle management of medical devices for treatment of acute ischemic stroke. Your responsibilities will include various aspects of the product's lifecycle, including material changes, process improvement, regulatory submissions, shelf-life studies, and responding to sales & marketing requests.
The successful candidate will have an in-depth knowledge of current products from a technical point of view: design, materials, performances, manufacturing process. You will manage project sub-parts as part of a larger project team, provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
Responsibilities:
* 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: design, materials, performances, manufacturing process
* Manage project sub-parts as part of a larger project team
* 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
Required Skills and Qualifications
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
Benefits
As a member of our team, you can expect:
* Opportunity to work with a ground-breaking biomedical operation
* Part of a company with an excellent record in employee continuous professional development and business improvement
* Dynamic and inspiring working environment
* Opportunities to work on challenging projects and assignments
* Possibilities for further personal and professional development/education
What Awaits You
This is your chance to take on new challenges and grow with us. Don't miss out on this exciting opportunity!