Manufacturing TechnicianReporting StructureThis person shall report to the Senior Manufacturing Engineer or designate.Overall Job ObjectivesThe Manufacturing Technician supports day-to-day production by maintaining efficient and compliant operations on the manufacturing line. Key responsibilities include troubleshooting issues, performing equipment setups and maintenance, supporting process improvements, and ensuring accurate documentation in line with GMP and quality standards.The Manufacturing Technician will work as part of a team to assist in the manufacture of innovative medical devices in accordance with the requirements of International Standards: ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulation (MDR) and the Vivasure Medical Quality Management System.Main Duties and ResponsibilitiesProvide day-to-day technical support to the manufacturing line to ensure consistent and efficient operations.Respond promptly and effectively to manufacturing line stoppages or anomalies to minimise production downtime.Troubleshoot and resolve issues related to equipment, tooling, process, or material.Perform manufacturing line set-ups and operate equipment, ensuring proper use and functionality.Carry out routine and preventative maintenance on production equipment.Identify and implement improvements to manufacturing processes, tools, jigs, and methods that enhance product quality, efficiency, and manufacturability.Support the elimination of waste and inefficiencies using Lean, Six Sigma, or other continuous improvement methodologies.Participate in process development activities for new and existing products.Assist with equipment, process and product verification and validation testing.Maintain accurate and complete batch records, logs, check sheets, and maintenance records in compliance with GMP and quality system requirements.Conduct or support in-process inspection, functional testing, and non-conformance investigations.Maintain technical documentation in accordance with Quality Management System requirements.Provide input for risk assessments, FMEAs (Failure Modes and Effects Analysis).Collaborate with cross-functional teams during line validations, engineering builds or product transfers. Support product builder training on processes & work instructions.Work as part of the core manufacturing team to support root cause analysis and implement corrective and preventive actions.Maintain equipment, work areas and facilities to ensure a clean and safe work environment and compliance to good manufacturing practice.Qualification RequiredThird level qualification in a relevant technical field is advantageous.Knowledge of quality standards including ISO 13485, MDR, and FDA Requirements.Work Experience or Training Required2-5 years hands-on experience inMedical device / pharma industryOperating and maintaining production equipmentSupporting process improvementsWorking knowledge of QMS and regulatory requirements in the medical device industry.Special Skills RequiredExcellent communication and organisational skillsWorks effectively in a team environmentTakes ownership of responsibilities and can work autonomously as requiredGood documentation practices (GDP) and strong working knowledge of Microsoft Word, Excel, Powerpoint etc.Knowledge of cleanroom manufacturing processes and methodologiesAbility to read technical drawings, process diagrams, and equipment manuals.