Develops products, materials, processes, or equipment for medical device products in the treatment of heart disease.
Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
- Develops new ideas and technologies within an assigned product area.
- May co-ordinate activities of a number of technicians 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.
- Participates in design review and designing products and processes for fabrication.
- Develops production equipment and process improvements and innovations and is responsible for cost improvement programs.
- Ensures the efficient transfer of prototype and pilot products to full production status and supports these product lines on an ongoing basis.
- Communicates changes in project milestones and writes project reports as required
- 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.
- Understands and complies with complex regulations, including FDA & ISO, governing the quality systems
- 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 Degree in either Mechanical, Polymers, Chemical, Materials or Biomedical Engineering. Min. FETAC level 8
- Strong R&D experience preferably in the health care industry.
- Excellent interpersonal and communication skills with good 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 please contact Roisin McNamara on 091730022 / email@example.com
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