The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the production/manufacturing department.
- 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.
- 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 validations
- 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.
- Engineering Degree or equivalent
- A minimum of 3 years’ engineering 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.
To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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