Ballinasloe, Galway County, Ireland
The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the production/manufacturing/Lifecycle Management functions.
- Provide technical support on all product and processing related issues.
- Manage production processes ensuring that target yield, capacity, throughput time and productivity are achieved.
- 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 all stakeholders across the business to ensure that the transition of products through product lifecycle 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.
Competencies and Attributes
- 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.
- Is creative, continually learning and exploring new ideas.
- High level of flexibility required regarding role and prioritisation of activities
- A self-starter applies his/her own initiative in most situations.
- A good team player who works well in a team environment.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Ability to stay connected to multiple projects simultaneously.
- Proactively enacts change where required and implements new processes and routines to give effect to that change
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