
Principal Technical Specialist
7 days ago
Ballybrit, Galway
- Excellent salary, bonus, pension, healthcare and opportunity to grow your career with a Medical Device organisation.
- Company: A global leader in neurovascular care with a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
The role of Senior R&D Engineer II involves managing and delivering R&D activities associated with the lifecycle management of the portfolio of products for treatment of acute ischemic stroke with significant technical challenges.
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.
- 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.
- 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.
- A minimum of 5 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
- 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.
- This is an 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.
- 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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