An exciting permanent R&D Engineer opportunity has arisen with a leading multi-national medical device leader in Galway as a result of continued expansion of their operations.
Job Purpose
Develops products, materials, processes, or equipment for projects of moderate complexity. 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 creates and maintains design-related technical notes (notebooks, protocols, validations, qualifications, manufacturing documents, etc.) building a complete design history.
Responsibilities
- Lead design change activities throughout the commercial Drug Eluting Stent/Cutting Balloon business ensuring product safety, compliance, material continuity and cost reduction.
- Ability to multi task and demonstrate flexibility across multiple functions.
- Communicates changes in project milestones and compile DCA's/technical reports as required.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Interfaces with Marketing, Operations, Quality Assurance, Reg Affairs, Vendors and Physicians.
- Must be able to provide technical guidance within a large team and be an effective communicator within a multidisciplinary and international organisation.
- Applies the Technical Development Process (TDP) and Product Development Process (PDP) methodologies.
- Demonstrate a primary commitment to patient safety and product quality.
- Understands and complies with all the regulations governing the quality systems.
- Motivated , self-starter who works within a team environment.
Qualifications
- 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
- Understands and complies with all the regulations governing the quality systems.
- Motivated, self-starter who works within a team environment.
- Excellent interpersonal and communication skills with proven leadership abilities
- Excellent analytical and problem-solving skills
- 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 a more detailed and confidential discussion on this role contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091-706718