Job title:Senior R&D Engineer
Location:Ballybrit, Galway
Benefits:Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation.
Company:
My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
About the role:
The role of Senior R&D Engineer II supports 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.
Overall responsibility for various aspects of the product's lifecycle including material changes, process improvement, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and returned product investigations.
Some responsibilities include:
- 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.
Requirements:
- 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.
What awaits you:
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
Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie