Our client, a leading medical device company located in Galway is recruiting for a R&D Engineer.
The successful candidate will be responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. The successful candidate 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.
- 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 analysed 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 mind set, identifies areas for improvement, suggests solutions, and submits patent disclosures.
- Summarizes, analyses 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
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects. Demonstrate a primary commitment to patient safety and product quality.
- Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Build Quality into all aspects of work by maintaining compliance to all quality requirements
- HETAC Level 8 Degree in a relevant Technical Discipline, preferably Mechanical, Polymer, Materials or Biomedical Engineering.
- Strong R&D/technical experience preferably in the health care industry
- Excellent interpersonal and communication skills with proven leadership abilities.
- Excellent analytical and problem-solving skills.
- Candidates should have a proven track record of working in a fast paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.
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