Key Responsibilities:
The successful candidate will provide daily support and work on projects, NPI, processes, materials, and equipment to achieve production goals.
* Analyse processes, product, material or equipment specifications and performance requirements.
* Responsible for the introduction/transfer and validation of new equipment.
* Troubleshoots new products / process working closely with product development.
* Continuous Improvement & Yield Analysis.
* Engaging with technicians, operators, and other cross-functional teams to ensure business process success.
* Contribution in NPI (New Product Introduction) development
* Execute new equipment introductions and carry out validations.
* Root cause analysis using Lean tools and techniques.
* Writing and improving process procedures.
* PCA (Process Change Analysis) From Documentation to Implementation
* Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
Qualifications and Experience:
We are looking for a highly skilled professional with:
* NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
* Minimum 2-5 years' experience working at an Engineering level, ideally in Medical Device industry or other highly regulated environment desirable.
* Automated Manufacturing equipment experience advantageous but not essential
* Process & Equipment validations IQ/OQ/PQ desirable