Job title: Lifecycle Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with a hugely exciting Medical Device organisation. Company: My client is a Medical Device company that has recently been acquired by a multinational, a global leader in neurovascular care. They have a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke. My client invests in their people, taking great pride in providing a positive work environment that respects diversity, supports wellbeing, and embraces innovation. About the role: The R&D Sustaining Manager will be responsible for managing design changes and sustaining activities, providing technical leadership and judgment to a team of engineers in the life cycle of a portfolio of devices to treat ischaemic and haemorrhage stroke. Some responsibilities include: Responsible for R&D (LCM) activities for the portfolio of products. R&D team leadership, with responsibility for team structure, team development, and performance management. Identify critical project tasks, define project strategy, and set team priorities. Develop detailed project goals, plans, and budget. Report progress across the organisation. Organizing and prioritizing activities, including escalations, in collaboration with key functions and aligning on deliverables and timing. Manage interfaces between other functions, especially Supply Chain, Quality and Regulatory, to plan and support R&D activities required to support product lifecycle management. This includes working with: Quality and Design Assurance in risk identification and assessment of any design and process changes, R&D representative for re-certification and vendor audits. Supply Chain and Manufacturing in developing and implementing cost improvement programs with external manufacturing partners. Support R&D department with customer (physician) visitors in terms of presenting on the development history of our product portfolio. Support customer complaint technical investigations and site representative for review meetings. R&D point-person to review complaint trending, alert and action levels. Contribute to the cultural development of the R&D department by identifying opportunities for improvements in ways of working, and proactively implementing ideas for continuous improvement. Requirements: Honours degree in Engineering or Science (desired) with strong technical acumen. Significant experience in an R&D or product sustaining role in the medical device industry. Team leadership experience required. Ability to work within design control systems and processes. What awaits you: This is an opportunity to work with a ground-breaking biomedical operation, part of a company with an excellent record in employee continuous professional development and business improvement. An opportunity to be part of a global market leader. A dynamic and inspiring working environment. Opportunities to work on challenging projects and assignments. Possibilities for further personal and professional development/education. Excellent benefits. This role is subject to equal employment opportunity and affirmative action laws and regulations. We are an equal opportunities employer and welcome applications from all qualified candidates. #J-18808-Ljbffr
Technical Life Cycle & Engineering Manager Job title: Technical Life Cycle & Engineering Manager Location: Ballybrit, Galway – Hybrid working model Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with a hugely exciting Medical Device organisation. The role leads a multi-functional team in the development and production of medical devices used for the treatment of stroke. This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight. The Technical Life Cycle Management and Engineering (TLCME) team are tasked with collaborating with R&D to provide technical expertise for the production of acute ischaemic stroke devices. As this position will lead a portfolio of projects. Some responsibilities include: Demonstrate proven hands-on engineering skills in the development of new processes. Manufacturing & Project activity at contract manufacturing organisations, including product builds, product quality issue resolution, process development, technical training, validation, and continuous monitoring of manufacturing performance Provide Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts. Develop and implement equipment and/or process improvements that will improve efficiency, product yield, and equipment reliability. Lead the implementation of new manufacturing processes and equipment to support the assembly of new products. Represent Supply Chain on strategic new projects including breakthrough manufacturing technologies. Requirements: Mechanical or biomedical engineering degree or equivalent. Proven experience within a GMP regulated Medical Device Industry. Project Management experience or alternatively a key core team member as part of a project team. Experience in special processes, for example, catheter assembly, polymer processing (compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing), welding, equipment & tool design. People management experience leading a team of engineers We are an equal opportunities employer and welcome applications from all qualified candidates. #J-18808-Ljbffr
Principal Engineer Our client, a multinational healthcare company, are currently seeking a Principal R&D Engineer to join their team. The Principal Engineer will report to an R&D Director and will work on development of a portfolio of devices and be R&D Subject Matter Expert in the organization. Role/Responsibilities Responsible for providing technical leadership to support device development across portfolio. Development of the device design requirements and specifications and for performing robust device and product characterization throughout the design development program. Responsible for technical interface between drug product and device teams during combination product development on elements such as primary container interface and compatibility, exhibit batch manufacture and shelf life studies. Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications. Responsible for metrology, engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/ leachable, specifications & method development and transport & shipping studies. Trending and statistical analysis of analytical and manufacturing data including compilation of technical reports to support combination product development lifecycle. Responsible for critical review of the device analytical and manufacturing control strategy for projects by ensuring regulatory requirements are incorporated into development plans. Responsible for compilation and review/approval of technical documentation within the group Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system. Skills/Experience The ideal candidate will be a qualified, experienced professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment. Masters/Degree in Engineering/Science with 7 years’ experience in a late stage R&D or Technical Support environment Previous experience of working as an Engineer or Scientist role in a regulated and GMP environment on injectable devices Previous experience in compiling analytical and/or manufacturing control sections of regulatory submissions is desirable A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage. Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management. Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders Some travel will be required as part of this role #J-18808-Ljbffr
R&D Manager Our client a high potential medical device start up are currently seeking an R&D Manager to join their team. Reporting to VP of R&D the R&D Manager will be responsible for management of people and departmental activities within the R&D/Product Development functions encompassing all activities leading to clinical and commercial approval. Role/Responsibilities: Recruit, manage and develop Senior and R&D engineers, providing them with clear goals and objectives and development feedback and opportunities. Seek opportunities for the building of continuous clinical and technical knowledge and expertise within the staff. Support the development of departmental and program objectives, attached to a strategic plan, to ensure the technology reaches its potential, and the departmental resources develop to facilitate this. Manage health and safety with the test laboratory. Support the development and maintenance of departmental budgets and resourcing plans. Ensure interactions with colleagues/stakeholders fully reflects the company values Ensure the implementation of robust engineering practices and process in the design and development of the product to ensure the final product is reliable and of the utmost quality. Ensure that test plans and testing executed aligns with regulatory requirements. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support clinical activities including limited clinical case support. Perform root cause investigations of identified product failure modes. Support the ongoing development of the Companies IP portfolio. Keep abreast of technological changes within the therapeutic domain, ensuring that the company and staff are up to date with the state of the art in the areas of polymer material, nitinol, tissue engineering, test methods, imaging technologies among others. Keep abreast of changing regulatory standards, and how these can impact the planned technical work within the R&D and Product Development Activities. May manage the development of new products that meet patient, customer and business needs. May serve as the Project Lead on one or more project, developing plans and goals for the project which meet the overall company goals. Individually or in support role, develop project plans, timelines, budget and resource requirements and communicate these to stakeholders. Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond R&D. Manage external vendors/partners as necessary to support product development activities. Skills/Experience Minimum of Bachelor’s degree in Mechanical or Biomedical Engineering, or related field Minimum of seven (7) years in a similar role in medical device product development, with a minimum of 3 years in project management/leadership role of technical projects across R&D and Manufacturing as a Senior or Principal R&D Engineer. The projects should incorporate new product development (preferably in Class III cardiovascular devices). Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Demonstrated experience in people mentoring and development. Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into new product development. Experience in design, verification, and process validation processes. Broad knowledge of materials and manufacturing processes applicable to medical device industry is desirable. Experience working with sub-contract manufacturers/suppliers/test facilities, including integration of their activities into the product development activities. Previous experience of the planning and preparation of regulatory submission to agencies, competent authorities and/or Notified bodies. Excellent communication, organisational and time management skills. Good problem-solving mindset. Strong verbal and written communication skills. At ease in start-up environment and effectiveness to deliver in low-structured environments. Demonstrated ability to communicate within a team/company structure and to achieve project and company objectives. #J-18808-Ljbffr
Overview Purchasing & Planning Manager Our client is a leading manufacturer of disinfection products for the global market. They are seeking a Purchasing & Planning Manager who shall report to their Head of Operations. The role is on site in Wexford. The ideal candidate shall have a Bachelor’s degree in supply chain management, engineering or related field with experience in sales and operational planning systems. Responsibilities Responsible for production planning, raw materials planning/ordering, raw materials & finished goods warehouse as well as master data. Manage the plant supply chain activities with the focus on achieving the targeted OTIF (On-Time in Full) for customer deliveries. Manage a proper balance between financial targets, production targets (low production variability, high utilisation of equipment, good OEE performance – e.g. reduce losses through set-up times) and customer service/requirements. Manage the ordering of raw materials and ensure a proper supply to the related production departments to enable in-time production as scheduled. Continuously control & monitor major KPIs (OTIF for customers and suppliers, schedule adherence, inventory DOH, lead time), analyse root causes of deviations and implement actions for improvement. Lead and develop the Planning and Supply Chain teams. Manage appropriate inventory levels on raw materials, packaging, and finished goods. Build a flexible, agile supply chain approach (e.g., flexible shift models, processes ensuring higher flexibility such as FTO), including flexible packaging lines and related actions. Ensure that production planning is carried out and regularly check all SCM master data. Collaborate with Production and Quality departments to maintain a high level of customer service. Support monthly target setting and forecasting for plant output, cost absorption, inventory and shipment planning. Carry out capacity planning (short and long term) and modelling to identify pinch points and actions. Build a local S&OP process to guide site operations. Support budgeting for the area, create reports and analyses to support regular budget, review and planning meetings. Support R&D activities, new product introductions, product recertification and product rationalisation initiatives. Pursue world-class continuous improvement and problem-solving practices, including focus groups. Engage in ongoing education and development opportunities as directed by management. Ensure optimal use of resources and deployment across the organisation as required. Provide training to new and existing employees as needed. Coordinate and complete projects and other duties as assigned by management. Promote teamwork and contribute to problem solving and idea generation across the business. Maintain high standards of housekeeping, health & safety and GMP practices at all times. Perform any other tasks in line with the role as guided by management. Education & Experience Bachelor’s degree in supply chain management, engineering or related field. Experience in sales and operational planning systems. Excellent analytical and conceptual skills. Additional Requirements Decision making with tangible actions as appropriate. Result-oriented and analytical mindset. Positive mindset and good communication across hierarchical levels. Strong teamwork and collaboration skills. Ability to see the big picture from details and manage projects. Project management capability. How to Apply For further details please call Karen Shiel on 087 745 2487 or send CV in confidence to karen.shiel@lifescience.ie #J-18808-Ljbffr
A specialist recruitment agency is seeking a Director of Process Development to lead the design and optimization of manufacturing processes for medical device products. The ideal candidate will have over 10 years of experience in process development and manufacturing transfer within regulated industries. Responsibilities include managing the end-to-end lifecycle of process development, defining strategy, and ensuring compliance with quality systems. A Bachelor's degree in Chemical Engineering is required, along with advanced knowledge in related fields. #J-18808-Ljbffr
Managing Consultant at LifeScience Recruitment Job title: Director of Process Development Location: Limerick Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As a Development Director you will lead the design, optimization, and scale-up of manufacturing processes for biosynthetic, medical device products. This R&D role partners closely with Technical Operations, Supply Chain and Quality to ensure robust, scalable, and compliant processes from early development through to commercial production Role: Lead the end-to-end process development lifecycle for biosynthetic, medical device products, from concept through scale-up and commercial manufacturing transfer Define and execute the process development strategy, roadmaps, and risk management plans to ensure on-time, on-budget delivery with robust process performance Design, run, and analyze design of experiments (DOE) and other statistical methodologies to understand critical process parameters and their impact on quality and yield Develop scalable, robust manufacturing processes that meet quality, regulatory, and cost objectives; drive design for manufacturability and design-to-cost initiatives Plan and manage technology transfer activities from development to production lines, including support in process validation (IQ/OQ/PQ), commissioning, and start-up support Partner with Formulation, Technical Operations, Manufacturing, and Quality teams to select equipment, automation, and process technologies; evaluate capital project needs and contribute to / manage budget planning Experience required: Bachelor’s degree in Chemical Engineering or a closely related field with an advanced degree (MS/PhD) preferred 10+ years of experience in process development, process scale-up, and manufacturing transfer in medical devices or similarly regulated industries (e.g., pharma, biotech) with hands-on leadership responsibilities Deep knowledge of GMP/ISO 13485 quality systems, CAPA, change control, document control, and regulatory expectations for medical devices Proven expertise in process characterization, design of experiments (DOE), statistical analysis, and robust process validation (IQ/OQ/PQ) Strong background in one or more of the following process areas common to medical devices: polymer processing, lyophilization, polymer milling, coloration, and sterilization, with a bias toward reliable, scalable polymer manufacture Demonstrated success in technology transfer from development to manufacturing to meet commercial demand Excellent project management, planning, and budget management skills; ability to manage multiple programs concurrently Does this sound like your next career move for 2026? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie #J-18808-Ljbffr
Principal Instrumentation & Calibration Engineer - Maintenance & Reliability Principal Instrumentation & Calibration Engineer – Maintenance & Reliability Our client, global biopharmaceutical manufacturer, are currently recruiting for a Principal Instrumentation & Calibration Engineer to join their Maintenance & Reliability team on a permanent basis. This role provides instrumentation, calibration, and reliability expertise at a new biotech manufacturing facility. As Principal Instrumentation & Calibration Engineer you will own the site calibration program, ensure compliance with regulatory requirements, and drive reliability improvements to maximise equipment availability and performance. Responsibilities: Lead and manage the site calibration program and represent it during audits Own all site instrumentation systems (calibration, troubleshooting, upgrades, obsolescence, MTBF, etc.) Ensure maintenance and reliability strategies align with global standards Analyse predictive/condition-based monitoring data and drive follow-up actions Develop and maintain SOPs, job plans, and CMMS data Provide technical support, training, and guidance to maintenance teams Lead continuous improvement initiatives in reliability and compliance Manage spare parts and inventory for critical equipment Requirements: Degree in Electrical & Instrumentation Engineering (or equivalent) 5+ years’ experience in maintenance/engineering (preferably pharma/regulated industry) Strong knowledge of EU directives (e.g. ATEX) and international standards (IEC, ISO, ISA, etc.) Expertise in troubleshooting, calibration systems, and equipment reliability Strong communication, problem-solving, and technical reporting skills Self-starter with ability to work independently Strong teamwork, customer focus, and flexibility Commitment to safety, quality, and compliance For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie #J-18808-Ljbffr
A leading medical devices company based in Galway is looking for an experienced Quality Engineer to join their Operations team. You will ensure quality and compliance in manufacturing processes through developing quality assurance procedures, working closely with suppliers, and guiding the operations team. The role requires at least three years of experience in the medical device industry and a relevant degree. Competitive salary and comprehensive benefits package offered. #J-18808-Ljbffr
A medical device company in Dublin is seeking a Senior Electronic Engineer to support hardware development for medical device products. The ideal candidate will have over 5 years of experience in the medical device industry, strong problem-solving skills, and a solid foundation in electronics. This role offers a dynamic work environment with a focus on cross-functional teamwork and innovative projects. #J-18808-Ljbffr
