- Type: Permanent
- Location: Clare
- Salary: €55k-€65k
- Job Ref: SME63255
- Date Posted December 13, 2017
Our multi-national Healthcare client is currently seeking a Senior Manufacturing Engineer to join their expanding team. If you are looking to join a progressive organisation with a great working environment, flexible working arrangements and an attractive package this may be the opportunity for you.
The primary purpose of this role will be to introduce and develop the manufacturing equipment for the urine strip product. This includes the development and provision of user requirements specification, finalization of supplier quotations, procurement, installation, commissioning, and validation support for the setup of required equipment. The incumbent will liaise with requisite departments to ensure the equipment is fully validated and installed in line with current FDA/ISO requirements.
- Lead and deliver the manufacturing engineering activities of a project to establish, implement and validate the operation of a new manufacturing operation with the business objectives of quality, performance and cost.
- Work with cross functional project team to solve problems, manage and achieve project KPI’s & milestones required to deliver on all project targets.
- Responsible for the management of the project deliverables to ensure on time launch of a lean manufacturing operation with an optimized value stream from the outset.
- Direct efforts to ensure that all processes, equipment, materials and methods that are used in the manufacturing of the products are as per requirements and in compliance.
- Ensure that all new manufacturing equipment and processes installed meet requisite timelines, safety, quality, capacity, GMP, and ISO 13485/FDA requirements.
- Provide ongoing support for the equipment maintenance of the urine strip product.
- Participate in 3P workshops, equipment design reviews, factory acceptance tests, user requirement specifications and layout development.
- Participate in the introduction of new reagents, new manufacturing processes/systems/procedures and equipment into the facility. Transfer and implement processes from other manufacturing facilities.
- Liaise with equipment vendors from procurement to manage safety, quality, on time delivery and cost, through to installation, commissioning and validation.
- Providing technical leadership on process issues. Responsible for establishing technical standards. Leadership of projects to resolve complex technical issues regarding equipment. Use of tools and techniques to streamline start up processes and ongoing operations e.g. SW, TPM, OEE, kaizen planning event, tools and drive projects forward using Daily Management.
- Responsible to develop and maintain visual project management boards and conduct daily meetings at Gemba to drive project deliverables.
- Prepare project reporting for leadership be a member of the project leadership core team with responsibility for engineering
- Third level Degree or equivalent in Engineering. A minimum of 5 years relevant manufacturing experience in the Diagnostics Industry is required. Experience in project management and a strong understanding of GMP, ISO/ FDA requirements are required.
- Experience working with Clinical Chemistry/ Immunoassay/ Urine strip manufacturing processes would be an advantage.
- Experience in a lean manufacturing environment preferred
- Microsoft office suite/CAD, MS Project are preferred