Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Role Manage team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of valve assemblies Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements. How Will You Make an Impact? Manage supervisors and/or oversee the work of assigned quality assurance team within own function, one or more production line or projects. Develop a robust talent development plan in alignment with functional growth strategies of the department. Identify opportunities and lead the implementation of changes to drive improvements Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups Collaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementation Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re‑design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow‑up on action items in collaboration with cross functional groups Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department Provide technical guidance to cross‑functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity Lead the implementation of CAPA program including training, approvals, and system effectiveness What You Will Need? Bachelor's Degree in Science or Engineering field Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices or equivalent work experience based on Edwards criteria Demonstrated track record in people management or equivalent work experience based on Edwards criteria Experience working in a regulated industry or equivalent work experience based on Edwards criteria What Else We Require? Proven successful project management leadership skills Proven expertise in both Microsoft Office Suite, including advanced Excel and related quality systems Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Expert understanding of quality procedures while addressing issues with impact beyond own team based on knowledge of related disciplines Expert understanding of related aspects of quality processes and/or systems Expert knowledge of financial acumen as it relates to quality Expert knowledge of applicable quality regulations (e.g., cGMP compliance) Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business Strict attention to detail Ability to interact professionally with all organizational levels and proactively elevate issues to appropriate levels of management in the organization Ability to work and excel within a fast‑paced, dynamic, and constantly changing work environment Knowledge of Lean Manufacturing concepts and Six Sigma Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team Participate and present at meetings with internal and external representatives Resolve operational and scheduling issues Dedicated to quality client service and pro‑active and responsive to client needs. Develop peer, cross‑functional and cross‑business relationships to maximize best practice sharing and team effectiveness. Develop relationships and leverage them to influence change Support and solicit input from team members at all levels within the organization Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Excellent problem‑solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards) Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing Knowledge of financial acumen as it relates to the business as well as quality engineering #J-18808-Ljbffr
Edwards Lifesciences in Shannon, Ireland is looking for a Quality Assurance Manager to ensure efficient operations of the site quality system while managing the quality assurance team. The ideal candidate will have a Bachelor's degree in Science or Engineering and experience in managing audits for medical devices. Responsibilities include overseeing compliance methodologies, leading process audits, and driving quality improvements using Lean and Six Sigma principles. Competitive salary and benefit package available. #J-18808-Ljbffr
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Role Manage team and responsible for facilities and reliability engineering functions within assigned manufacturing plant. How Will You Make An Impact? Has overall responsibility of facilities and assets through their lifecycle including design, construction, implementation, and maintenance. Manage resources including expense priorities, capital and expense budgeting (e.g., AOP), and facilities and asset management (e.g., metrology/calibration, facility machine shop, critical systems, and spare parts. facilities and equipment maintenance, reliability engineering and other engineering services) Develop long term capital planning and execution plans aligned to the organization's strategy. Drive culture, engage staff morale and ensure employees' safety. Direct team members and develop a robust talent development and succession planning in alignment with functional growth strategies across the engineering organization Set facilities and equipment management, maintenance, asset management, predictive maintenance, and equipment reliability strategy around efforts to optimize business processes. Define and implement core competencies, by assessing business needs and developing, proposing and implementing solutions Collaborate with network leadership to develop operational strategy. Partner with cross-functional groups/resources to achieve tactical execution plans of business objectives to ensure operational excellence, risk identification and reduction in compliance with quality, safety, and environmental standards Negotiate and oversee the development and execution of plans, budgets and schedules for all facility and equipment modifications, expansions, shutdowns, infrastructure programs, capital investments for lifecycle management, capacity, upgrades and/or new construction in partnership with cross-functional teams. Anticipate business needs from an infrastructure standpoint and propose strategies to address Responsible for general plant-wide manufacturing and shared services, contract management (e.g., security, cafe, cleaning services, services and service contracts, pest control) and establishing appropriate performance measures, SLA (Service Level Agreements), and standards Collaborate with BU, Corporate, and other plants in the Global Supply Chain network maintain processes standardization and leverage best practices Responsible for and drive the implementation of site facilities master plan. Oversight on cleanroom qualification, construction, controlled manufacturing drawings/procedures, and validations of the manufacturing plant Drive a value stream mindset and culture of continuous improvement based on lean and Six Sigma principles and EW Production System (EPS) What You Will Need? Bachelors Degree in Engineering Demonstrated track record in operations management Experience working in a regulated industry What Else You Require? Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems Expert understanding of related aspects of facilities and asset management Expert knowledge of financial acumen as it relates to facilities and asset management Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of facilities and asset management to the business Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT Strict attention to detail Ability to interact professionally with all organizational levels and proactively elevate issues to appropriate levels of management in the organization Ability to work and excel within a fast paced, dynamic, and constantly changing work environment Knowledge of Lean Manufacturing concepts and Six Sigma Interacts with senior management, and others concerning matters of significance to the company Conduct business and technical briefings for senior and top management and for external representatives Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization Dedicated to quality client service and pro‑active and responsive to client needs. Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness. Provide leadership and direction to large cross‑functional teams to successfully implement global enterprise systems and related solutions Develop relationships and leverage them to influence change Support and solicit input from team members at all levels within the organization Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control #J-18808-Ljbffr
A leading global medical technology company seeks a Facilities Engineering Manager in Limerick. The ideal candidate will manage facilities operations and ensure asset reliability within manufacturing. Responsibilities include developing capital plans, optimizing processes with lean principles, and managing collaborations with cross-functional teams. A Bachelor's degree in Engineering and a proven track record in operations management in a regulated industry are required. This position emphasizes quality, safety, and proactive client service. #J-18808-Ljbffr
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. As a Quality Inspector you will assess devices in‑process and upon completion, review accompanying documentation, and conduct audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed. Working Hours: 4 Day Week, Monday to Wednesday (4:30PM-3AM), Thursday (4:30PM-2AM) Key Responsibilities Perform visual, dimensional, and functional inspection on a wide variety of components and/or finished medical device products using tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements. Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications. Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards. Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilizing a variety of computer programs to perform and/or document specific job tasks. Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction. Perform line clearance and verification of inspection. Perform verification of manufacturing documents with component and device drawings. Support the training of other inspectors through work demonstration and feedback. May ensure smooth shift transitions by providing status de‑brief of shift activities. Participate in special projects, performing Test Method Validations (TMVs), protocols, first‑article inspection, etc. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period. Other incidental duties: general work area housekeeping. Education and Experience 2 years of previous related experience, including GMP and GDP required. Leaving Certificate or equivalent preferred. Additional Skills Good communication skills. Able to read, comprehend, speak, and write English. Basic computer skills, required, including working knowledge of manufacturing software. Strict attention to detail. Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing. Ability to use applicable tools and equipment, hand‑eye coordination, and high manual dexterity. Full understanding of applicable inspection procedures. Continuously expands proficiency in inspection techniques. Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System). Must be able to work in a team environment and with minimum supervision by following detailed work instructions. Ability to effectively provide and accept feedback from colleagues. Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. #J-18808-Ljbffr
A global medical technology company in County Limerick, Ireland seeks a Quality Inspector to ensure compliance with high standards during the product development lifecycle. The role requires conducting inspections, operational audits, and maintaining documentation standards while collaborating with teams. Ideal candidates should have prior experience in GMP/GDP and a focus on quality. The position offers a structured work week with early hours, emphasizing teamwork and attention to detail. #J-18808-Ljbffr
A global medical technology company in County Limerick seeks an experienced Senior Engineer to lead technical projects in designing complex automated equipment. This role involves collaboration with cross-functional teams, risk assessments, and ensuring compliance with industry standards. The ideal candidate holds a Bachelor's degree in Engineering with 4 years of automation experience. Strong leadership, communication, and problem-solving skills are essential. You will contribute significantly to patient outcomes and innovation in medical devices. #J-18808-Ljbffr
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer position is a unique career opportunity that could be your next step towards an exciting future. How you will make an Impact: Provides technical leadership in the design and development of complex automated equipment and assemblies, with strong understanding of mechanical and automated systems design validation and integration. Have detailed knowledge of Design platforms including 3D CAD (e.g., SolidWorks, Creo, Inventor) and simulation packages. Ability to produce detailed engineering drawings, BOMs, and URS documentation to Medical Device standards. Develop design calculations, simulations, and engineering analyses (e.g., FEA, tolerance stack-ups), FMEA and machine safety CMSE experience Evaluate design concepts for feasibility, manufacturability, cost, and performance. Perform stress analysis, material selection, fluid/thermal calculations including CFD, and reliability assessments. Review and approve vendor equipment designs and proposals. Conduct design reviews, DFMEA, and risk assessments. Ensure designs meet internal standards, industry codes, and regulatory requirements (ISO, ASME, PED, etc.). By driving cross functional alignment between multiple functions within the business and ensuring robust, compliant and efficient manufacturing process. Establish strategic and detailed plans to tackle diverse and complex tasks, such as testing issues and machine issues which require analysis, data, and in-depth evaluations. These tasks support the design, prototyping, assembly, and development of improvements and/or automation of existing processes and mechanical components. Lead and drive the development and manage the execution of complex projects or experiments. Lead collaboration with cross-functional partners to conduct complex technical experiments, research, and design various prototypes to achieve consensus and make informed technical decisions. Lead improvement activities within internal or external teams, or manufacturing processes to drive enhancements and improve efficiency. Utilize metrics to perform continuous improvement. Train, coach, and guide junior/senior engineer on complex technical task. Review works and may direct others to supervise. Lead the development and influence multiple development teams and various technical domains to support and drive improvements and changes. Establish and enforce engineering standard, best practices, and methodologies to ensure efficiency and quality engineering results. What you will need (Required): Bachelor's Degree in Engineering or Scientific field , 4 years experience working in automation domain What else we look for (Preferred): Whichever applicable, expert skills (with years of proven record) in mechanical design, or programming skills (PLC, Robotics, or vision), or electrical design Demonstrates proficiency in creating excellent technical documentation, white papers, and technical write-ups Ability to translate technical information to all levels of the organisation Capable of delivering effective presentations on complex technical information and project activities Knowledge of applicable FDA regulations for medical device industry is a plus Substantial understanding of processes and equipment used in assigned work Extensive knowledge and understanding of principles, statistic, theories, and concepts relevant to Engineering Advanced problem-solving, organizational, analytical and critical thinking skills with proven record Strict attention to detail Ability to manage competing priorities in a fast paced environment, including the ability to manage vendors and project stakeholders Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills Must be able to work in a team environment, including frequent inter-organisational and outside customer contacts Represents organisation in providing solutions to difficult technical issues associated with specific projects Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Ability to interact professionally with all organisational levels Demonstrates strong technical leadership, influences multiple development teams and various technical domains, supports and drives company improvements and changes. #J-18808-Ljbffr
