Job Overview:This company has an opportunity for a Manufacturing NPI (New Product Introduction) engineer to support the operations team as we ramp through pilot production to commercial launch.Responsibilities:- Responsible for the execution of equipment, process and test method validations.- Support the manufacturing process, understand the process risks and identify mitigationsleading to improving yields and process efficiency.- Responsible for tracking and executing of New Product Introduction activities ahead of product commercialisation.- Work with equipment vendors to identify areas for process improvement.- Create a strong culture of problem solving using standard tools like DMAIC and 6 sigma.- Create and follow a process development plan ensuring budget, risk and timeline have a high level of focus placed on them.- Work closely with the R&D team to ensure their programs are also facilitated in the production plans.- Work with R&D on materials, process and equipment improvement projects.- Create and update existing master validation plan for the line equipment.- Responsible for all line equipment, ensuring maintenance and calibration is up to date.- Execution of IQ/OQs for lab and production equipment.- Communicate and update project activities using project management methodologies.Background & Qualifications:- Bachelors in Mechanical Engineering, Manufacturing, Chemical Engineeering, BiomedicalEngineering or other relevant engineering discipline.- At least 2 years work experience in a manufacturing or process development related role in a medical device company.- Experience with new equipment introduction (IQ/OQ) and process characterisation andvalidation.- Experience with process characterisation and process validation, including test methodvalidation,- Experience with processes like Lyophilisation.- Demonstrated experience with GDP & GMP standards.- Have an excellent knowledge of engineering materials used in medical device manufacturesuch as hydrogels, metals and polymers.A strong problem solver with knowledge and experience of DMAIC or other problem-solvingtools.- Must be organised, demonstrate innovation, and have a strong work ethic on individual projects and as part of a project team.- Effective communication skills. Both verbal and written - English.- Extremely comfortable with hands-on and technical work.Desired Skills and ExperienceManufacturing, NPI, Mechanical Engineering, Biomedical Engineering, Process Development, IQ/OQ, Lyophilisation, Validation and testing, Chemical Engineering,Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
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