Our client, a medical device company in Galway is currently looking to recruit a Manufacturing Engineer for their site.
Summary of the Role:
- Engineer required to support existing and future implant-medical-device manufacturing lines and systems, daily cleanroom operations and driving a lean, KPI-driven and continuous improvement culture across the department.
- Involvement as a key member on new product transfer teams taking new devices from R&D/Concept phase into commercially-approved manufacturing.
- In depth training and particular emphasis will be provided in the areas of medical device textiles and vascular grafting and coating technologies and in the model for transferring same into manufacturing.
- The suitable candidate will be expected to participate in projects and interact with customers during the development and introduction of new products and technologies.
- This position will involve overseeing the maintenance and calibration of critical equipment-systems.
- There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an IS013485 organisation.
- The candidate should have a strong background in manufacturing, mechanical, production, biomedical engineering or other related disciplines.
The Manufacturing Engineer will be principally engaged in the following tasks:
- Assists in new product transfers from Design into Manufacturing Release.
- Work closely with a project manager and extended cross-functional team to oversee the efficient introduction of new manufacturing products and technologies on site into cleanroom environments.
- Provides support to the manufacturing organization to facilitate efficient operations within the production area.
- Support the development of a KPI-driven Production Management System on site
- Optimize operations utilising Lean, Six Sigma, Value Stream Mapping and Problem-Solving Tools
- Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
- Interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
- Support continual improvement in production areas and leads key projects
- Interact with Customers and Vendors during development and introduction of new products, processes and technologies.
- Manages 10, OQ & PQ Validation activities
- Generate validation and test protocols, monitor testing, issue qualification test reports and approve components for use in products.
- Responsibility for management of the Calibration and Preventative Maintenance programs.
Disireable Skills & Qualities:
- The successful candidate should possess a Bachelor's of Science degree in Engineering, Biomedical Engineering or related field.
- Candidate must be highly motivated and passionate about process development / improvement with strong documentation, oral, and interpersonal communication skills required.
- Demonstrated problem solving skills are important.
- This position has responsibility to make necessary decisions and/or take action, which is required to carry out job duties
For further information on this Manufacturing Engineer role in Galway please contact please contact Caroline Kingston on 086 8395531 / firstname.lastname@example.org
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