Our client, a medical device company in Galway is currently looking to recruit a Senior R&D Engineer for their site.
- Responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. Successful candidate will work independently, or 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.
- Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects
- Under limited supervision/guidance, compiles, analyses, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
- 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.
- Works independently to plan and schedule own activities necessary to meet timelines.
- 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 co-ordinate activities of a number of staff in an assigned phase of a development project.
- Interfaces with Marketing, Operations, Quality Assurance, vendors and possibly physicians.
- Defines, prototypes, clinically tests and transfers new product to production.
- Leads or participates in a cross functional team to perform troubleshooting on products/process problems as related to design, material or process.
- Ensures the efficient transfer of prototype and pilot products to full production status and supports these product lines on an ongoing basis.
- Promote an innovation mind-set, identifies areas for improvement, suggests solutions, and submits patent disclosures.
- Able to provide technical guidance 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.
- Communicates changes in project milestones to key stakeholders and writes project reports as required
- 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
- Primary Level 8 Degree in Mechanical, Polymer, Chemical, Materials or Biomedical Engineering. An advanced degree is a distinct advantage.
- Minimum of 6+ years’ experience preferably in the health care industry and / or equivalent Masters / PhD in relevant discipline.
- Strong R&D/technical experience preferably in the health care industry and capable of handling the development aspect of assigned projects. Prior experience in interventional, vascular or cardiac surgery arena a plus, especially involving prosthetic and catheter-based technologies.
- 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.
For further information on this Senior R&D Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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