Are you a manufacturing engineer looking to progress your career? Are you interested in taking the next step in your professional journey with a global leader in the medical device industry? Are you ready to challenge yourself in a fast-paced and high-regulated environment? You could be the perfect candidate for this opportunity Don't hesitate, apply todayJob DescriptionOur client in Galway require an experienced Manufacturing Engineer with a background in electronics engineering to support an upcoming project. This role will focus on manufacturing process development for New Product Introduction. You will be based onsite and work directly with manufacturing process owners.Key ResponsibilitiesIndividuals more than 2 years med device experience in Manufacturing, Quality, or new product introduction (e.g. process development) roleFamiliar with Manufacturing Documents (e.g. SOP's, change control, process risk (e.g. PFMEA) and validation (IQ, OQ & PQ) documentsWriting/approving validation protocols and Process Characterisation reports (where required)Writing/Reviewing and approving Repeat Action Assessments (RAA) and Acceptance Equipment List (AEL's)Reviewing, updating, and approving Manufacturing Instruction (SGOI's) and MES documentsOwner of DMR remediation NCEP/CAPA's ( if they occur)Key RequirementsEngineering degree with 2-3 years' relevant industry experience; preference for medical deviceBackground in process development for NPI'sStrong technical writing and documentation skills.Knowledge of 21 CFR Part 820, ISO 13485.BenefitsCompetitive and attractive employee compensation packagePension contributionsHealth insurancePaid public holidaysLocation:Galway, Ireland | onsiteDesired Skills and ExperienceIndividuals more than 2 years med device experience in Manufacturing, Quality, or new product introduction (e.g. process development) roleFamiliar with Manufacturing Documents (e.g. SOP's, change control, process risk (e.g. PFMEA) and validation (IQ, OQ & PQ) documentsWriting/approving validation protocols and Process Characterisation reports (where required)Writing/Reviewing and approving Repeat Action Assessments (RAA) and Acceptance Equipment List (AEL's)Reviewing, updating, and approving Manufacturing Instruction (SGOI's) and MES documentsOwner of DMR remediation NCEP/CAPA's ( if they occur)Engineering degree with 2-3 years' relevant industry experience; preference for medical deviceBackground in process development for NPI'sStrong technical writing and documentation skills.Knowledge of 21 CFR Part 820, ISO 13485.