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 Vanessa Lynch on 086 0462367 / firstname.lastname@example.org Check out all our open jobs on our HERO Recruitment website – www.hero.ie
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