Work on transcatheter heart valve devices from project concept through product developoment and post commercialisation.
R&D Engineer is responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. They will work as a member of a team within a dynamic New Product Development organisation specialized in transcatheter heart valve system development for commercialization in all major global healthcare markets.
Research & Development Engineer
Galway , Ireland
The successful candidate will join a dynamic team in developing products, materials, processes, tests or equipment for medical device products in the treatment of heart disease. This candidate will participate in an interdisciplinary team of engineers working on transcatheter heart valve devices from project concept, through product development and post commercialisation.
- Develops new ideas and technologies within an assigned area.
- May co-ordinate activities of a number of technicians in an assigned phase of a development project.
- Develops product, test equipment or process improvements and innovations and is responsible for cost improvement programs.
- Undertakes and successfully completes complex product development tasks including: writing and/or verifying specifications, design verifications and design validations; maintaining product/process documentation; developing test methods.
- Use of design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process. Whenever product changes are proposed, justification is written, or data is collected to verify that the design intent is still met.
- Designs and coordinates standard engineering tests and experiments.
- Designs, procures and fabricates tooling and fixtures
- Applies Mechanical and Biomedical Engineering knowledge to the design, development and sustaining of prosthetic heart valve systems.
- Create/develop technical capabilities and expertise related to the design and testing of heart valve technology.
- Devise strategies for efficient execution of project deliverables and communicates changes in project milestones to key stakeholders and writes project reports as required
- Interfaces with Marketing, Operations, Quality Assurance, vendors and possibly physicians. Work collaboratively with manufacturing to reduce product costs through design improvements.
- Defines, prototypes, clinically tests and transfers new product to production and supports these product lines on an ongoing basis.
- Leads or participates in a cross functional team to perform troubleshooting on products/process problems as related to design, material or process.
- Promote an innovation mindset, identifies areas for improvement, suggests solutions, and submits patent disclosures.
- Summarizes, analyzes and draws conclusions from test results and prepares standard reports/documentation to communicate results to technical community.
- Able to provide technical input within a large team and be an effective communicator within a multidisciplinary and international organisation.
- Lead and solve complex problems to resolution and solution implementation.
- Understands and complies with complex regulations, including FDA & ISO, governing the quality systems
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers related to materials, manufacturing processes and design
This fulltime position offers competitive salaries and fantastic career progression. Benefits include; pension, healthcare for the employee and dependants, bonus and paid annual leave.
- Up to 3 years’ relevant experience in the medical device industry.
- Experience should ideally include R&D or manufacturing activities while operating in an ISO 13485 compliant Design Control System and should involve experience in Design Verification and Validation.
- Good communication and interpersonal skills
- Able to prioritise project tasks and meet deadlines
Galway is a harbour city on the Atlantic coast of the West of Ireland. It is Ireland’s 5th largest city with a population of nearly 80,000. Well-connected by road and rail networks to the larger cities of Dublin and Limerick, living in Galway offers the opportunity to experience real Irish life while still being reassuringly accessible. Serviced by two international airports within an hours drive, Shannon Airport and Ireland West Airport in Mayo, it’s a short flight from London and all the major European cities.Learn more about Galway
Millions of expats have chosen to come, live and work in the Republic of Ireland. This English speaking European island has been influencing the world for generations. With good political and cultural connections with the EU, Britain and the US, Ireland is in a very strong position economically. With great job opportunities, a thriving industry and attractive lifestyle, it’s no wonder Ireland is an attractive prospect for ambitious individuals looking to further their career.Learn more about Ireland