
Innovative Medical Device Developer
2 days ago
Overview of the Role:
This is a dynamic opportunity for an experienced engineer to join our team in leading the development of innovative medical devices. As a Senior R&D Engineer, you will be responsible for overseeing various aspects of the product lifecycle, including material changes, process improvements, regulatory submissions, shelf-life studies, and responding to sales and marketing requests.
Key Responsibilities:
- Oversee product/process optimization projects in collaboration with Supply Chain and Quality teams.
- Acquire in-depth knowledge of current products from a technical perspective, including design, materials, performance, manufacturing processes, and support second supplier and/or technical transfer projects.
- 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.
- Investigate product complaints and analyze returned devices.
- Support CAPA and Non-Conformance processes.
- Evaluate and scope process changes, material changes, and vendor changes.
- Support Labelling changes and implementation.
Qualifications:
To be successful in this role, you will require:
- 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 Awaits You:
This is an exciting opportunity to work with a ground-breaking biomedical organization, part of a company with an excellent record in employee continuous professional development and business improvement.
Benefits:
As a valued member of our team, you can expect:
- 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.
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