About the Company NovintiX NovintiX is a fast-growing engineering solutions and digital transformation & technology consultancy that partners with leading Life Sciences and MedTech companies across the US, Ireland, and Europe. We specialise in delivering high-impact digital programmes, engineering services, and talent solutions that support innovation, efficiency, and regulatory compliance. Our clients include some of the worlds top medical device and pharmaceutical brands. Job Summary We are seeking a technically skilledLOTO (Lockout/Tagout) Engineer with a strong maintenance and engineering background to support a leading medical device manufacturing facility. The ideal candidate will be hands-on with equipment such as CNC machines and large vacuum plasma systems, and will be responsible for creating detailed, machine-specific energy control procedures to ensure safe maintenance and servicing operations. This is a highly specialised technical role focused on energy isolation procedure development for complex machinery. It does not involve marking floors, conducting risk assessments, or general EHS administrative tasks. Key Responsibilities Develop and documentmachine-specific energy control procedures (ECPs) for complex manufacturing equipment, including CNC machines and vacuum plasma systems. Identify and isolateall energy sources (electrical, mechanical, pneumatic, hydraulic, thermal, etc.) associated with each machine for safe maintenance. Collaborate with Maintenance, Engineering, and Equipment teams to understand operational specifics and isolation requirements. Support validation and vendor teams by reviewing new equipment for compliance with lockout/tagout safety standards and energy isolation best practices. Ensure procedures meet relevant regulatory and safety compliance standards (e.g., OSHA 1910.147, ISO 13849). Provide technical input during equipment upgrades, installations, and commissioning related to energy isolation. Requirements Bachelors Degree in Engineering (Electrical, Mechanical, or related discipline) or equivalent technical qualification. Minimum of3 years of hands-on maintenance experience in a manufacturing or regulated industry environment. Proven ability to work directly with machinery to identify energy sources and developtechnical LOTO/ECP documentation. Strong working knowledge ofCNC systems, vacuum/plasma equipment, and complex electromechanical systems. Deep familiarity withenergy isolation methods, machine safety protocols, and lockout/tagout best practices. Knowledge of regulatory standards includingOSHA 1910.147 andISO 13849. ???????? ???? ?????????? Opportunity to work on cutting-edge medical manufacturing projects with global visibility. A fast-paced, empowering work environment where your expertise is valued. Access to innovation-driven leadership and a chance to impact large-scale manufacturing strategy. Skills: LOTO EHS Machine Safety Lockout Tagout CMSE Electrical Engineer
12+ years of experience in ETL / Data Testing / Data Quality, including team leadership. Strong experience with Azure Databricks and Azure Data Factory. Expert-level Python for automation frameworks and validation utilities. Strong PySpark expertise for validating large-scale transformations and datasets. Advanced SQL skills for reconciliation and issue analysis. Experience defining and enforcing data quality standards at scale. Define and govern ETL testing standards, automation strategy, and best practices. Design and standardize Python- and PySpark-based automation frameworks. Establish validation approaches for ADF and Databricks pipelines. Define data quality rules for analytics-ready datasets (completeness, consistency, volume, schema). Review and approve test plans, automation design, and execution results. Lead and mentor ETL testing engineers; conduct code reviews for automation assets. Define and track data quality metrics and test effectiveness KPIs. Coordinate testing across multiple releases and delivery teams. Act as the escalation point for critical data quality or release issues. Collaborate with Data Engineering and DevOps teams to integrate testing into Azure DevOps CI/CD. Skills: ETL Testing Python Pyspark Azure Data factory Azure Data Bricks SQL
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
Maintenance of EHS management system in line with internal and regulatory requirements ensuring procedures and other documents are kept up to date. Preparation and delivery of training programmes including induction and job specific EHS topics Conducts regular EHS inspections and audits to monitor the effectiveness of the EHS management system and highlight any areas for attention/action. Preparation of EHS reports/metrics for both internal and external stakeholders Leads on EHS issues, stays abreast of evolving standards and technological solutions. Readily shares expertise with others Leads the Emergency Response Programme ensuring the procedures, resources and training are in place to deal with all likely emergency scenarios on site Ensures a robust EHS incident investigation process is in place. Monitors incident trends identifying areas requiring action. Leads investigations as necessary. Assesses the EHS impact of proposed changes to plant, process, equipment etc. and identifies actions to ensure compliance and risk control. Ensures effective risk assessment and risk reduction programmes are in place for the site Monitors EHS legislation ensuring site compliance with current and future requirements as necessary. Maintains waste management requirements and environmental monitoring programme in line with licence requirements Leads EHS projects on site and/or across Ireland UK region as required and supports cross functional teams Collaborates with site leadership to ensure alignment on priority EHS issues and plans to address same. Promotes and supports a culture of accountability and collaboration in relation to safety and environmental performance and expectations Manages spend in line with budget and drives efficiencies and cost savings across EHS service and equipment providers. What you will need Third level qualification (minimum NFQ 8) in EHS, Engineering or Science discipline or equivalent combination of education, training and experience. 6+ years experience in a manufacturing environment or equivalent Ongoing professional development in the area of EHS desirable Exceptional EHS experience and implementation of processes/systems to ensure regulatory compliance and continuous improvement. Ability to interpret EHS/regulatory requirements and lead programmes to meet requirements and bring performance to the next level. Proven strong stakeholder management skills and ability to influence at all levels. Extensive experience in implementing and maintaining EHS management systems. Comprehensive experience in dealing with EHS regulators e.g. H.S.A., E.P.A, Local Councils etc. Relevant professional body qualification or accreditations.
Role Overview As a PLC Automation Engineer, you will be responsible for developing, implementing, and maintaining automation solutions across manufacturing equipment and processes. You will collaborate with cross-functional engineering, quality, and operations teams to ensure reliable, compliant, and efficient production of medical devices. Key Responsibilities Design, program, and troubleshoot PLC-based control systems (Siemens, Allen-Bradley, etc.) for automated equipment. Support installation, validation and commissioning of new automated systems. Develop HMI/SCADA systems for operator-friendly interfaces. Ensure compliance with FDA, ISO 13485, and GxP standards in all automation activities. Collaborate with Manufacturing Engineering, Quality, and Maintenance teams to improve reliability and efficiency. Conduct root cause analysis and resolve automation-related issues with minimal downtime. Manage preventive and predictive maintenance strategies for control systems. Document software, configuration changes, and validation protocols as per regulatory requirements. Support continuous improvement projects (Lean, Six Sigma, Industry 4.0) with automation solutions. Train technicians and operators on equipment functionality and safety protocols. Qualifications & Skills Bachelors Degree in Electrical / Electronics / Mechatronics / Automation Engineering (or related field). 5+ years of experience in PLC automation engineering, preferably in the MedTech, Pharma, or High-Tech Manufacturing sector. Hands-on experience with PLC programming (Siemens S7, Allen-Bradley, Omron, etc.) and HMI development. Knowledge of industrial networks (Ethernet/IP, Profibus, Profinet, Modbus). Excellent troubleshooting, problem-solving, and analytical skills. Ability to work cross-functionally in a fast-paced manufacturing environment. Good communication and documentation skills. Preferred Skills (Nice to Have) Experience with robotics, vision systems. Familiarity with 21 CFR Part 11 compliance for electronic records. Exposure to MES (Manufacturing Execution Systems) and Industry 4.0 technologies. Lean Six Sigma Green Belt or equivalent certification. Skills: HMI PLC Programming Allen Bradley S7 SCADA Control Logic PLC Allen Bradley
About the Opportunity NovintiX is seeking a Manufacturing Engineer to join our team in Cork, working with a premier medical device manufacturer. This position offers the chance to play a key role in advancing innovative healthcare solutions. The selected candidate will oversee daily operations related to projects, products, and equipment, ensuring production targets are met. You will also contribute to process enhancements, collaborate with suppliers and R&D teams, and support new material and product introduction initiatives. Key Responsibilities Evaluate and interpret specifications for processes, products, materials, or equipment to ensure optimal performance. Under general direction, collect and analyze operational, test, and experimental data to define benchmarks for new or updated products and processes. Review and interpret test outcomes, providing actionable insights to resolve technical challenges. Diagnose and resolve issues in new products or processes, partnering closely with product development teams. Collaborate with cross-functional groups to address production and engineering challenges. Perform hands-on troubleshooting of equipment and coordinate solutions with technical teams. Drive initiatives for process optimization, layout improvements, and enhanced operational efficiency. Support technicians, operators, and cross-disciplinary teams to achieve project and business objectives. Participate in the introduction of new products, contributing technical expertise from concept through implementation. Utilize Lean methodologies and root cause analysis tools to identify and address process issues. Develop and maintain technical documentation, including process and quality validation protocols. Apply knowledge of process mapping, risk assessment, and validation strategies. Foster a culture of continuous improvement and best practice adoption through active team engagement. Ensure compliance with health, safety, and environmental regulations in all engineering activities. Train and mentor team members, promoting knowledge sharing and technical excellence. Prioritize product quality and safety, adhering to all relevant industry standards and regulatory requirements. Qualifications & Skills Bachelors or Masters Degree in Engineering (mechanical, Manufacturing, Biomedical, etc.,) or a related technical field. Proven experience in a manufacturing or process engineering role, preferably within the medical device sector. Strong analytical and problem-solving abilities. Hands-on experience with process improvement methodologies (e.g., Lean, Six Sigma). Excellent communication and teamwork skills, with the ability to work effectively across functions. Familiarity with regulatory standards and quality systems in the medical device industry. Demonstrated ability to manage multiple priorities and deliver results in a fast-paced environment. Skills: Manufacturing manufacturing engineer
