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Senior R&D Engineer

Job Title: Senior R&D Engineer
Contract Type: Permanent
Location: Galway
REF: 90420
Job Published: 13 days ago

Job Description

Contact: Bimi Felix
Telephone: 0868395533

Senior R&D Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior R&D Engineer for their site.

Job Purpose
  • Responsible for design and development next-generation minimally invasive medical devices for the treatment of valvar heart disease. Successful candidate will work independently, or as a member of a team within a dynamic New Product Development organisation specialized in Tran's catheter heart valve system development for commercialization in all major global healthcare markets.
  • 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.
Key Responsibilities
  • 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.
  • Apply Mechanical and Biomedical Engineering knowledge to the design, development and assessment of prosthetic heart valves.
  • 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.
  • Participates in design review and designing products and processed for fabrication.
  • 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 mindset, identifies areas for improvement, suggests solutions, and submits patent disclosures.
  • Lead and solve complex problems to resolution and solution implementation.
  • 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 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 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 0868395533 /
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