A leading medical technology company in County Limerick is seeking a Quality Engineer II to optimize product development and ensure compliance with industry standards. You will be responsible for developing experiments, investigating manufacturing quality issues, and creating training materials. The ideal candidate holds a Bachelor's Degree in Engineering or a related field and has at least one year of relevant experience. Strong problem-solving, documentation, and interpersonal skills are essential for this role. #J-18808-Ljbffr
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of ground‑breaking 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. The Quality Engineer II applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards’ systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. How you’ll make an impact: Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyse results, make recommendations, and develop reports. (R&D: 30) Investigate moderately complex manufacturing product quality and compliance issues which may include: Investigate PRAs and complaints for manufacturing related issues Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyse results, Provide technical support to external and internal audits, Make recommendations and develop reports. (MFG: 45 / R&D: 15) Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes. Develop, update, and maintain technical content of risk management files May develop, update, and maintain technical content of risk management files, review and revise PFMEAs in conjunction with BU PMS team where applicable for the plant site. Oversee product release, assess and disposition product on hold (MRB), and manage material quality control. Review and approve equipment validations and asset management actions. Collaborate with engineering teams to ensure successful transfers Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re‑design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk Provides support to the following: Process validation or support/lead TMV Sustaining Quality Engineering responsibilities such as review Quality Metrics, Material Review Boards, Quality Control etc PMV, Process Validation plans Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Other incidental duties assigned by Leadership What you’ll need (Required): Bachelor’s Degree in an Engineering or Scientific field and 1 years experience in a similar role What else we look for (Preferred): Good computer skills in usage of MS Office Suite; CAD experience preferred Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment required Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering Solid problem‑solving, organizational, analytical and critical thinking skills Solid understanding of processes and equipment used in assigned work Knowledge of and adherence to Quality systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including the ability to manage vendors and project stakeholders Ability to build productive internal/external working relationships 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
Director, Engineering Process Automation Type Full time Category Location Ireland-Limerick Job reference Req-42405 Posted for 4 days ago 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 Engineering Automation position is a unique career opportunity that could be your next step towards an exciting future. The Director of Engineering will develop and drive Process Automation in providing technical expertise in the design, prototyping, assembly, development, and troubleshooting of innovative automation system in partnership with R&D and NPD groups. Continuing to innovate and improve by extracting more opportunities and benefit from automation technology. How you'll make an impact: Initiate and lead the design, prototyping, assembly, development, and troubleshooting of highly complex automation systems in support of R&D, New Product Development / Introduction, instilling DFM.Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups and key stakeholders. Oversee, inspire, and develop SMEs, and retain a technical talent to ensure automation knowledge continuity and knowledge transfer capabilities from Singapore site to the global. Develop a robust talent development plan in alignment with functional growth strategies of the department. Manage resource planning, project planning, budgeting, expense priorities, performance management, and working through team managers to achieve results. Identify opportunities for and drive the development and management of multiple, highly complex automated systems that resolve manufacturing and/or product inspection challenges. Provide insight to stakeholders on current automation capabilities to ensure they are reusable in broader initiatives while developing new capabilities Build strong relationships with stakeholders, ensuring collaboration, professionalism and cooperation against scope, timelines and budget for strategic automation program activities. Embrace Agile Methodology and working efficiently with ambiguity. Responsible for the tactical execution of value stream mindset and culture of continuous improvement based on Edwards Production System (EPS) What you'll need to have (Required): Minimum Bachelors degree in Engineering or related Track record in management of technical and/or automation disciplines and/or agile methodology Experience working in a regulated industry What else we look for (Preferred): Proven successful project management leadership skills Proficient in both Microsoft Office Suite and Solidworks Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Determines or effectively recommends course of action after considering potential risks of alternatives Ability to read and interpret drawings per ASME Y14.5 Ability to translate technical information to all levels of the organizations Experience in PLC logic and programming, and integration of sensors, sub-systems, and controllers Preferred Experience in development, integration, and programming of Vision Systems Preferred Extensive knowledge and understanding of principles, theories, and concepts relevant to controls engineering Demonstrated ability to work with teams to complete critical milestones under pressure with short deadlines Expert knowledge and understanding of mechanical design & machine building practices Expert understanding of fixture development & system integration Expert understanding of materials and manufacturing processes Extensive understanding of Six Sigma concepts with proven ability to apply to 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 Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below. #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 Engineering Automation position is a unique career opportunity that could be your next step towards an exciting future. The Senior Manager will develop Process automation in providing technical expertise in the design, prototyping, assembly, development, and troubleshooting of innovative automation system in partnership with R&D and NPD groups. Continuing to innovate and improve by extracting more opportunities and benefit from automation technology. How you'll make an impact: L ead the design, prototyping, assembly, development, and troubleshooting of highly complex automation systems in support of New Product Development / Introduction, instilling DFM.Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups and key stakeholders. Lead and develop SME ’ s and retain a technical talent to ensure automation knowledge continuity and knowledge transfer capabilities from the Ireland site to Delivery System Network . Develop a robust talent development plan in alignment with functional growth strategies of the department. Manage resource planning, project planning, budgeting, expense priorities, performance management, and working through team managers to achieve results. Identify opportunities for and drive the development and management of multiple, highly complex automated systems that resolve manufacturing and/or product inspection challenges. Provide insight to stakeholders on current automation capabilities to ensure they are reusable in broader initiatives while developing new capabilities. Write and submit successful proposals for automation and digital grant funding to external agencies. What you will need to have (Required): Minimum Bachelors degree in Engineering or related Experience in Automation deployment Track record in management of technical and/or automation disciplines and/or agile methodology Experience working in a regulated industry What else we look for (Preferred): Proven successful project management leadership skills Proficient in both Microsoft Office Suite and Solidworks Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Determines or effectively recommends course of action after considering potential risks of alternatives Ability to read and interpret technical drawings Ability to translate technical information to all levels of the organizations Experience in PLC logic and programming, and integration of sensors, sub-systems, and controllers Preferred Experience in development, integration, and programming of Vision Systems Preferred Extensive knowledge and understanding of principles, theories, and concepts relevant to controls engineering Demonstrated ability to work with teams to complete critical milestones under pressure with short deadlines Expert level of knowledge and understanding of mechanical design & machine building practices High level of understanding of fixture development & system integration High level of understanding of materials and manufacturing processes Extensive understanding of Six Sigma concepts with proven ability to apply to projects Adhere to all company rules and requirements (e.g., 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 medical device company based in County Limerick is seeking a Manufacturing Engineer to optimize manufacturing processes and improve patient outcomes. The role involves developing experiments, resolving compliance issues, and training technicians. Ideal candidates will hold a Bachelor's Degree in Engineering or a related field and possess good problem-solving and organizational skills. This role is vital in ensuring quality in medical device manufacturing, working both independently and in a team setup. #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 Manufacturing Engineer position is a unique career opportunity that could be your next step towards an exciting future. The Manufacturing Engineer applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. Working Hours: Monday to Thursday (4:30pm - 3am, Finish at 2am on Thursday's shift) How you'll make an impact: Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement Develop basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports Analyze and resolve basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) Identify opportunities for re‑design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work What you'll need (Required): Minimum Bachelor's Degree in an Engineering or scientific field required What else we look for (Preferred): Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable) Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment preferred (if applicable) Good understanding and knowledge of principles, theories, and concepts relevant to Engineering Good problem-solving, organizational, analytical and critical thinking skills Good understanding of processes and equipment used in assigned work Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors Ability to build stable working relationships internally 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
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 Manufacturing Engineer position is a unique career opportunity that could be your next step towards an exciting future. The Manufacturing Engineer II applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. How you'll make an impact: Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement Develop basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports Analyse and resolve basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work What you’ll need (Required): Bachelor’s degree in an Engineering or Scientific Field and a minimum 2 years’ experience in a similar role What else we look for (Preferred): Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable) Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment preferred (if applicable) Good understanding and knowledge of principles, theories, and concepts relevant to Engineering Good problem-solving, organizational, analytical and critical thinking skills Good understanding of processes and equipment used in assigned work Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors Ability to build stable working relationships internally 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 Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds. Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below. #J-18808-Ljbffr
A leading medical device company in County Limerick seeks a Manufacturing Engineer II to optimize manufacturing processes. The ideal candidate will have a Bachelor's degree in Engineering, 2 years' experience, and strong problem-solving skills. Responsibilities include improving manufacturing methods, developing process documentation, and training technicians. Join a team dedicated to improving patient lives through innovative technologies. #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 EHS Engineering position is a unique career opportunity that could be your next step towards an exciting future. The EHS Engineer will support and Develop EHS site programmes, maintain EHS compliance and employee health. How you’ll make an impact: Responsible for developing, implementing, and maintaining environmental, health, and safety programs to ensure compliance with regulatory requirements and company standards. Collaborate with cross‑functional teams to develop and implement processes to ensure compliance with EHS goals and programs. Provide EHS expertise for new processes, new products, and technologies and participate in the change control process of the site. Conduct risk assessments and job safety analysis relevant to the site needs. Compile, analyse, and evaluate EHS data relevant to the site needs. Conduct incident investigations, root cause analysis tools and identification of controls and prevention of reoccurrence. Develop and revise EHS training and written programs to ensure compliance with all applicable EHS regulations; may deliver training as necessary. Support maintenance of ISO 14001 and ISO 45001 Management System Certification. Conduct periodic internal inspections and audits to ensure continuous compliance with applicable regulations; and provide guidance to appropriate team members. Other duties as assigned by management. What you’ll need (Required): Minimum Bachelors degree in a relevant Scientific/ Engineering Field plus at least 2 years industry experience in a similar role. What else we look for (Preferred): Good computer skills in usage of MS Office Suite. Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills. Solid understanding and knowledge of EPA, HSA, local regulations. Solid problem‑solving, organizational, analytical and critical thinking skills. Solid understanding of processes and equipment used in assigned work. Knowledge of and adherence to Edwards Environmental Health and Safety and Quality. Strict attention to detail. Ability to interact professionally with all organizational levels. Ability to manage competing priorities in a fast-paced environment. Must be able to work in a team environment, including the ability to manage vendors and project stakeholders. Ability to build productive internal / external working relationships. 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
Join to apply for the Senior Engineer, Process Automation role at Edwards Lifesciences 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 Engineering Automation position is a unique career opportunity that could be your next step towards an exciting future. The Senior Automation Engineer provides technical Support in the development of a complex automation system, driving cross functional alignment and ensuring robust, compliant and efficient manufacturing process. How you'll make an impact: Development of bespoke automation solutions based on technology roadmap, with ownership for funding proposals, initial design, development of proof of concept, system testing, solution provider/supplier selection and management, and rollout of automation solution to other sites. Experience in the space of robotics, vision and electrical preferred These tasks support the design, prototyping, assembly, and development of automation of existing processes and mechanical components. Support the design activities, analysis, modification, and integration of robotics, automation technologies, and processes related to equipment. Ensures applicability to programs and products, handling high complexities Complete proposals for funding of automation solutions for internal and external audiences Collaborate 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. Support the development and influence multiple development teams and various technical domains to support and drive improvements and changes. Establish and enforce engineering standards, best practices, and methodologies to ensure efficiency and quality engineering results. What you'll need (Required) : Bachelor's Degree in Engineering or a Scientific field, and a minimum of 4 years experience working in automation domain (robotics/vision or electrical experience preferred) 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 organizations 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-organizational and outside customer contacts Represents organization 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 organizational levels Demonstrates strong technical leadership, influences multiple development teams and various technical domains, supports and drives company improvements and changes. Edwards Lifesciences is an Equal Opportunity Employer. #J-18808-Ljbffr
