Looking for a Manufacturing Engineer with at least three years’ experience in the Medical Device industry for a role with an expanding Medical Device company in Co. Galway. This is a four-day week role as the plant is closed on Friday.
- Provide technical support on all product and processing related issues.
- Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved
- Experienced in Product Transfers and Manufacturing process set up and scale up
- Apply “Lean” principles to production lines considering flow optimisation, throughput time, product movement, layout and space.
- Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment.
- Set up Preventive Maintenance and Calibration routines.
- Provide ongoing day to day support to Production; continually seeking to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot production related issues, implementing “robust permanent fix” solutions.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Work Instructions, Manufacturing procedures and Logs.
- Set up and order Product, Components, Consumables, and Material necessary for validation and production.
- Manage Tooling and Equipment spare parts inventory to support manufacturing capacity.
- Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validation
- Partner with R&D, Quality and Operations to ensure that the transition of Balloon products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective
- Engineering Degree or equivalent.
- A minimum of 3 years’ experience working in a similar role. Catheter manufacturing knowledge is highly desirable.
- Strong technical understanding of set up and maintenance of manufacturing processes. Experience in validation, equipment design and Lean Manufacturing highly desirable
- Proven technical expertise and competence across all aspects of manufacturing engineering function including lean.
- Demonstrated expertise and detailed knowledge of the medical device industry.
- Equipment Procurement and Validation experience
- Has conducted IQ/OQ/PQs and/or validations previously in a regulated environment. Effective knowledge of the regulatory environment in which the business operates.
- Proven written and oral communication skills and an ability to prepare competent business cases.
- An analytical approach to problem solving
- Good oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
- Ability to stay connected to multiple projects simultaneously.
If you are interested in this role, please send your resume to email@example.com or call me on 091 455 300.
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