Telephone: 086 3073779
Our client, a medical device company in Galway is currently looking to recruit an Manufacturing Engineer for their site.
Key role responsible for manufacturing engineering within a start-up medical device company manufacturing a device for treatment of structural heart disease
- Preparation of all relevant manufacturing specifications.
- Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Competent in validation requirements on new equipment introductions/processes/process changes
- Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production.
- Drive process improvements/capacity increases through New technology/equipment introductions
- Lead or actively participate in cross-functional teams to ensure projects are completed in a timely and efficient manner
- May serve as a representative or liaison to other sites or any external organizations, boards or committees.
- Project Management; Creates, drives, communicates & executes project plans, tasks and deliverables. Manages time to meet project deadlines
- Develops processes, materials and solutions through in house and out of house development paths.
- Uses structured problem solving techniques and statistical methods for data driven analysis and decisions
- Builds Quality into all aspects of work by maintaining compliance to all quality requirements
- Provides technical guidance to technicians and product builders
- May supervise other team members
Skills, Qualifications & Experience
- A graduate in Engineering/Technical field with typically 4 years in a medical device environment or equivalent.
- Experience with medical products such as large calibre delivery systems is an advantage
- Knowledge and understanding of validation processes
- Experience in regulated industry, FDA, ISO, etc.
- Demonstrated ability to lead / contribute to significant projects to completion, on time and within budget