About the Role We are looking for a Senior Business Systems Analyst to act as the bridge between shop-floor manufacturing operations and digital systems in highly regulated MedTech and Pharma environments. This onsite role focuses on CNC machining, CMM inspection, MES, QMS, and Industry 4.0 initiatives, working closely with plant stakeholders and offshore engineering teams. Key Responsibilities Lead shop-floor discovery across CNC, CMM, MES, QMS, and related manufacturing systems Document As-Is / To-Be processes, workflows, traceability, inspection, and rework loops Analyze machine and system data (CNC, CMM, MES; MTConnect, OPC-UA, logs) Identify digitalization, automation, and data capture opportunities Translate business and operational needs into BRDs, FSDs, user stories, SOPs, and data models Ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDR, GxP, and validation standards Support cloud, on-prem, and hybrid deployments in collaboration with IT/OT teams Act as the onsite liaison between plant teams and offshore engineering partners Support UAT, dashboards, ML model reviews, and change readiness activities Required Skills: 5+ years experience in MedTech, Pharma, or regulated manufacturing environments Hands-on exposure to CNC machining, CMM inspection, or precision manufacturing Strong understanding of MES, QMS, SCADA, or shop-floor digital systems Proven experience producing business and functional documentation Ability to interpret machine data and translate it into system and reporting requirements Experience working with manufacturing, quality, engineering, and IT/OT teams Preferred / Nice-to-Have Experience with MTConnect, OPC-UA, machine connectivity, or IoT gateways Exposure to manufacturing digitalization, predictive analytics, or machine monitoring Experience with CSV, validation-ready documentation, and regulated system deployments Background in medical devices, implants, instruments, or precision machining Qualifications Bachelors degree in engineeringor a related discipline Certifications in Lean, Six Sigma, Agile Business Analysis, or Industry 4.0 are an advantage Why Join Us? Work onsite with leading MedTech and Pharma manufacturing facilities in Ireland Be at the forefront of Industry 4.0 and manufacturing digitalization Collaborate with global engineering and technology teams Opportunity to make a direct impact on quality, compliance, and operational excellence Skills: CNC Machining CMM Inspection Precision Manufacturing manufacturing systems business analyst MES Business Analyst Industry 4.0