Manufacturing Engineer | Medical Device Company
The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the production/manufacturing department.
Location: Co. Galway
- Attractive Salary
- 4-day working week
- Annual Bonus
- VHI health Insurance for the employee (spouse and kids if applicable)
- Defined Contribution pension
- Stock options grant available
- Long term disability + Death in service cover up to 4x lump sum salary
- Flexible working week (four days working week)
- Free car parking onsite
- Canteen facilities onsite
- Paid Holidays
Responsibilities of the Job:
- 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 validations.
- 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.
What we would like you to have:
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.
Equipment Procurement and Validation experience.
- Has conducted IQ/OQ/PQs and/or validations previously in a regulated environment.
If you are interested in this job and are a suitably qualified and experienced Senior Engineer, please contact Aaron Long at Sigmar Recruitment T: +353 91 749 264 | E: email@example.com
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