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.