Electrical Engineer sought for a leading Medical Device organization in Limerick, responsible for designing and implementing electrical systems for construction projects. Duties: Collaborate with project managers and design teams to develop electrical system plans, ensuring compliance with relevant codes and standards. Provide technical expertise in the design and layout of electrical systems for construction projects. Participate in design briefing and engaging in design reviews – ensuring user requirements are communicated and represented. Conduct regular quality checks to ensure the integrity and functionality of electrical systems. Implement and enforce quality control measures to meet industry standards. Champion safety protocols and ensure that all electrical installations meet safety regulations. Conduct safety audits and participate in safety meetings to promote a culture of safety on the construction site. Collaborate with other engineering disciplines to ensure seamless integration of electrical systems with overall project requirements. Manage project timelines and budgets related to electrical systems. Requirements: Bachelor's Degree in Electrical Engineering from an accredited institution. Proven experience as an Electrical Engineer in a construction setting. Familiarity with Medical Device Manufacturing or similar experience and project delivery structures. Minimum of 5 years of Industrial experience. Prior experience managing a portfolio of small to medium site-based capital projects in the field of facilities, utilities, and general site infrastructure. Good understanding of Project Controls in cost and schedule development, financial assessments, and adherence to budget and schedule.
Join a leading multinational medical device organization in Limerick as a Process Validation Specialist, utilizing six sigma statistical analysis and experimental design tools to characterize processes and support process validation activities. As a Process Validation Specialist, you will be responsible for performing process validation, writing and reviewing validation documents, and coordinating validation change control. You will also participate in cross-functional project teams and represent the department on project teams. Key responsibilities include: Performing process validation (OQ & PQ) by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements. Utilizing six sigma statistical analysis and experimental design tools to characterize processes and support process validation activities. Writing, executing, and reviewing all validation documents. Defining the requirements for Process Validation in alignment with approved SOPs. Executing test plans according to approved procedures, tabulating test results, and organizing data packages. Compiling and analyzing data, preparing reports and making recommendations for changes and/or improvements. Investigating and troubleshooting problems which occur and determining solutions. Coordinating and executing validation change control and preparation of protocols and reports. Participating on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups. Preparing summaries of validation testing for regulatory submissions, and presenting validations to regulatory agencies. Independently applying validation principles to work assignments, reviewing and approving documents and resolving problems. Coordinating assigned projects and representing department on project teams. Resolving validation issues of moderate scope with limited direct supervision. Requirements: Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience. Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation. Six Sigma Black Belt certified is preferred. Experience in Statistical analysis & experimental design is essential.
Seeking an experienced Manufacturing Engineer to join a pioneering medical device company in Cork, Ireland, responsible for developing and implementing manufacturing processes for a breakthrough single-use medical device. My Client is a leading medical device company based in Cork, Ireland, that has developed a breakthrough single-use medical device, Solo+ TTD, addressing pain points in the current treatment of surgical tympanostomy. This procedure is the most common done on children. The company has achieved significant milestones, including being crowned Seedcorn's Overall Winner for the Best Early Stage Company in 2014 and Emerging Medtech Company of the Year, Irish Medical Device Association (IMDA) in 2015. The team has successfully completed clinical studies, gained ISO 13485 certification, and obtained CE Mark for the Solo+ device in Europe. Job Role: Collaborate with cross-functional teams and external manufacturers to develop and implement new manufacturing processes. Optimise existing manufacturing processes to improve productivity, quality, and cost-effectiveness. Design, develop, and implement manufacturing processes, including equipment selection, layout, and validation activities. Conduct risk assessments and implement appropriate corrective and preventive actions. Lead process validation activities, including IQ, OQ, and PQ protocols. Develop and document manufacturing procedures, work instructions, and quality standards to ensure compliance with regulatory requirements. Provide technical support and troubleshooting expertise to resolve manufacturing issues. Participate in the design transfer process from R&D to manufacturing. Collaborate with suppliers to ensure the availability of high-quality components and materials. Implement and manage process controls, including statistical process control (SPC) techniques, test method validation and process validation activities. Qualifications and Skills: Bachelor's or Master's degree in Engineering or related field. Solid experience in medical device manufacturing, operations, and engineering. Strong knowledge of manufacturing processes, including assembly, testing, and packaging. Strong experience with quality management systems and regulatory requirements for medical devices. Proficiency in process validation, risk management, and statistical analysis techniques. Excellent problem-solving skills and the ability to analyse complex manufacturing issues. Strong communication and interpersonal skills to collaborate effectively with cross-functional teams. Detail-oriented with a commitment to maintaining high standards of quality and compliance. Experience with Lean Six Sigma methodologies is a plus. Knowledge of CAD software and experience in design for manufacturability (DFM) is desirable.
Medical Device Quality Assurance Role Summary: Responsible for ensuring product quality and regulatory compliance in a multinational organization. We're currently recruiting for an exciting opportunity with a leading multinational organization based in Limerick. This is an excellent position for anyone looking to join a company that is one of the best at what they do. Duties: Support the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to pertinent regulations while attaining operational effectiveness. Work with various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades. Run/Manage complaint investigation and resolution of same. Design and develop validation documentation to support business continuity, new process/product introductions and process improvement requirements. Implement and co-ordinate the change control process to promote timely approval of all supporting documentation. All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform. Education & Experience: Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.
QC Laboratory Technician role involves movement of materials, system transactions, and inspection of primary packaging for a leading Pharmaceutical organization. We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: Movement of materials across the network. System transactions including movement and shipping of samples across QC labs within the network. Knowledge and experience using systems such as GLIMS, LIMS, and SAP beneficial. Inspection of primary packaging. Participate in writing/revising/rolling out accurate operational procedures, training materials, and maintenance procedures for various Quality systems. Review, approve, and trend test results. Peer review other analysts' documentation, ensuring QC Right First Time KPIs are achieved. Participate in QC daily meetings and ensure effective communication of testing progress, deviations, etc. Ensure that all Quality Systems within the department are adhered to on a daily basis. Complete all documentation in compliance with GMP and GxP standards. Problem solving to get to the root cause of issues. Provide support with audit/inspection requirements to ensure department compliance/readiness. Collaborating with others by sharing your skill-set and expertise. Drive continuous improvement, perform root cause analysis on system failures. Requirements: Degree in Science, Engineering, or similar. 1 - 3 years' experience in the Pharmaceutical, Biopharmaceutical industry, or a similar operating environment which includes experience in a Quality function. Previous Analytical Experience.
Lead Heart Valve Implant Engineer sought for breakthrough heart valve replacement development in Galway, Ireland. Collaborate with cross-functional team to design, develop, and test next-generation aortic valve replacement device. Our client, a structural heart startup, is seeking a lead heart valve implant engineer to join their team to work on the development of a breakthrough heart valve replacement. Reporting to the CTO, this position will lead detailed design and development of a next-generation aortic valve replacement device from concept and pre-clinical trial evaluation through to clinical studies. Key Responsibilities: Leverage in-depth understanding of material development, nitinol, and valve interface requirements and test methodologies. Ensure all design and development activities meet required regulatory requirements per ISO 5840 and clinical end user requirements. Generate detailed component and subsystem drawings/designs using SolidWorks. Lead and mentor postdoctoral research candidates engaged in implant development activities at our academic partner institution including in silico and in vitro testing: FEA, CFD, FSI, hemodynamic performance analysis, etc. Maintain detailed records of design iterations, evaluations, test methods, and analysis. Create prototypes and design iterations and conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques. Develop effective bench test methods including conducting hands-on testing and builds. Maintain high standards of documentation of work during all project phases to support overall project requirements/deliverables and IP/patent disclosures. Generate R&D test protocols & technical reports. Complete comprehensive analysis of test data using statistical tools such as Minitab. Perform in-depth interpretation of results and generate detailed technical reports. Provide engineering support for pre-clinical trials and commercial readiness. Support activities on user evaluation studies to gather insight/feedback on device performance and refine product designs as required. Collaborate with delivery system development partners to optimize deployment of the next-generation valve implant. Primary contributor to cross-functional team risk management activities (Hazard Analysis/ FMEA) with ownership of implant performance and design actions. Contribute to project planning as part of the cross-functional team to effectively identify and manage implant schedule, resourcing, and reporting to meet overall project goals. Contribute as required to regulatory submissions, pre-submissions, and reviews with implant design and performance expertise. Stay up to date with emerging technologies and designs to identify opportunities for innovation and improvement. File and capture as appropriate innovative design features through Invention Disclosure Forms and support compilation of patent applications as required. Requirements: Minimum Bachelor of Engineering (Mechanical/Biomedical/Polymer). Experience in stent design, polymer processing, and/or heart valves. 5+ years of medical device process development/R&D experience. Demonstrated proficiency with SolidWorks modelling and engineering drawings. Familiarity with application of FEA / CFD towards implant development preferable. Direct Class III implant design experience. Understanding of regulatory requirements including ISO 5840, ISO 13485, and FDA regulation. Demonstrated ability to develop product-driven bench test methods and perform hands-on testing diligently. Technical leadership capability to coordinate efforts of graduate engineers, technicians, and FEA engineers.
Quality specialist sought for 11-month contract in Tipperary, Ireland, to support pharmaceutical production and quality systems. We're currently recruiting for an exciting opportunity with a leading multinational pharmaceutical organization based in Tipperary. This is an excellent position for anyone looking to join a team that is one of the best at what they do. Duties: Participate as functional expert in cross-functional team managing production right first time at Ballydine. Review and approve batch, cleaning and testing documentation. Ensure all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Support deviation investigations and process performance monitoring, perform trending on deviations raised to identify improvement initiatives. Provide detailed knowledge of quality systems in place and ensure root cause is identified and corrective actions completed. Guide on quality requirements to maintain validation status, including participation in process/product Risk Assessments. Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes. Ensure changes controls raised are documented, assessed and completed. Prepare Annual Process and System Reviews. Act as lead/team auditor to support internal GMP walkdown and scheduled audits. Participate in generation and communication of quality metrics. Creation, review and approval of quality procedures as required. Requirements: Degree or post-graduate qualification in Science, Pharmacy or equivalent. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise). Spray drying experience desirable.
Senior E&I Maintenance Technician A highly skilled maintenance technician is required to provide technical support to production in a regulated pharmaceutical environment. This is an excellent opportunity for an experienced maintenance professional to join a leading multinational organization and contribute to the success of their operations. The successful candidate will be responsible for: Providing effective technical support to production in all aspects of machine and equipment maintenance, installation, and modification. Operating and cleaning process equipment as necessary. Maintaining process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs. Ensuring effective management and equipment shutdown scheduling. Supporting maintenance planning and preventative maintenance through completion of planned and emergency work orders. Documenting maintenance work, including upgrades, made to existing equipment. Operating and monitoring production support equipment using MES/DCS and PLC based systems. Repairing complex systems, including Autoclaves, Glassware Washers, Single use mixers, HVAC, Isolators, filling line and inspection lines. Interpreting P&ID's, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. Supporting continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations. Performing root cause analysis of system failures and implementing subsequent corrective action. Supplying information and technical data for securing spare parts and equipment asset entry into the CMMS. Assisting in general facility upkeep and providing responsive customer support. Requirements: Time-served E&I Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline. Prior experience in a Good manufacturing Practices (cGMP) and regulated pharmaceutical production environment. Extensive hands-on experience of preventive/reactive maintenance.
We are seeking a skilled professional to join our team in Louth, working with a Pharmaceutical organization. This role involves project work and making a tangible impact. Key Responsibilities Manage event management systems, including review and approval of events and deviations. Design and approve batch records. Manage site change control systems. Approve and compile validation protocols and reports. Review and approve SOPs, work instructions, and forms from other departments. Coordinate and assist in preparation for regulatory and customer GMP inspections. Requirements Bachelor's degree in a scientific or technical discipline. Experience in quality within the biological and/or pharmaceutical industry. Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. This is an excellent opportunity for someone who is interested in project work and making a tangible impact. If you are a skilled professional with experience in quality within the biological and/or pharmaceutical industry, we encourage you to consider this role.
Senior Regulatory Affairs Specialist - Post Market job requires a highly experienced professional to implement post-market activities and ensure regulatory compliance in the medical device industry. Job Description My client is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation and respect, they work in a collaborative, empowering, and exciting environment. The Senior Regulatory Affairs Specialist will play a key role in the implementation of post-market activities, reporting to the Senior Regulatory Affairs Manager. This is a fantastic opportunity to add real value to the company's future success. Responsibilities: Implement PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions. Approve Vigilance/MDR reporting as defined in each territory. Support and lead Regulatory Post Market System improvements. Participate in the implementation of Field Safety Corrective Action plan and associated activities if required. Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions. Provide RA Support to relevant Design Teams for Key Projects identified by the company. Provide support to other RA Specialists in achieving success for the team. Manage and support trend data for regulatory reporting. Support Gap Assessment process and associated process improvements. Manage PMA Annual Periodic Reporting system and approval of annual documentation for submission to regulatory authorities. Manage post-market scheduling of RA activities for timely completion and submission to regulatory authorities. Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these. Implement Technical File for updates arising from changes. Identify and maintain awareness of new regulation requirements or changes required to be considered by the company for regulatory compliance in all territories for post-market activities. Requirements: A degree level qualification in Engineering, Science, QA, or related field is essential. A minimum of five years experience at a senior regulatory level in the medical device industry is essential. A minimum of five years' experience in the creation of regulatory submissions for premarket approval is required. Experience of FDA guidance for sterile implantable products in premarket approvals is desirable. Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.
