Draper, Utah, United States · On-site
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…
Skills: Quality Engineering, CAPA, NCR Management, Process Validation, Six Sigma
Irvine, California, United States · On-site
$145k–$205k/yr
Sr Mgr, Health Economic & Reimbursement This role represents an opportunity to join the Global Health Economics & Reimbursement (GHER) team supporting patient access to innovative transcatheter mitral and tricuspid valve…
Skills: Health Economics, Market Access, Reimbursement Strategy, Value Framework Development, Cross-functional Leadership
Sacramento, California, United States · On-site
$124k–$149k/yr
Make a meaningful difference to patients around the world. Driven by a passion to help patients live healthier and more productive lives, our Sales teams embrace Edwards Lifesciences’ values to build trusting, lasting re…
Skills: Device Handling, Clinical Implantation, Troubleshooting, Physician Education, Case Coverage
Irvine, California, United States · On-site
$121k–$171k/yr
Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient l…
Skills: Educational Program Development, Medical Affairs, Content Creation, KOL Engagement, Project Management
Irvine, California, United States · On-site
$112k–$134k/yr
Make a meaningful difference to patients around the world. As a part of the Field Clinical Specialist team, you will be a critical part of delivering our patient focused innovations, partnering with clinical professional…
Skills: Clinical Training, Case Management, Pre-case Planning, Post-case Management, 3 Mensio Management
Caesarea, Haifa District, Israel · On-site
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structur…
Skills: V&V Engineering, SolidWorks, Bench Testing, Cadaver Studies, Animal Studies
Garching bei München, Bavaria, Germany · Hybrid
Make a meaningful difference to patients around the world. Our University Programs are designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the…
Skills: Event Organization, Purchase Requisitions, Presentation Preparation, Calendar Management, Communication Planning
Shanghai, Shanghai, China · On-site
Manage the Channel Operations effectiveness of China. In charge of distributor front-to-end process included new distributor on board, renewal, termination, authorization change, cycle count, performance evaluation, trai…
Skills: Data Analytics, Channel Operations, Distributor Management, Inventory Management, Reporting
Irvine, California, United States · On-site
$121k–$171k/yr
Senior Product Manager, Global Training - Global Marketing, TMTT Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid…
Skills: Professional Education Development, KOL Engagement, Project Management, Structural Heart Procedures, Microsoft Office Suite
Irvine, California, United States · On-site
$81k–$114k/yr
At Edwards Lifesciences, patients are at the heart of everything we do. As a global leader in patient-focused medical innovations, we are dedicated to improving lives through breakthrough technologies. Our Research & Dev…
Skills: Mechanical Engineering, Rapid Prototyping, Design for Manufacturing, Design for Automation, Root Cause Analysis
Prague, Prague, Czechia · Hybrid
Make a meaningful difference to patients around the world. Our talented people are central to the future of Edwards Lifesciences, which is why our Human Resources teams help design, guide, and deliver inspiring experienc…
Skills: Compensation Analysis, Benchmarking, Job Profiling, MS Excel, MS PowerPoint
Cartago, Costa Rica · On-site
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…
Skills: Business Continuity Planning, Crisis Management, Business Impact Analysis, Risk Assessment, Incident Management
Irvine, California, United States · On-site
$92k–$130k/yr
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…
Skills: Labeling Design, Regulatory Compliance, Project Management, Cross-functional Collaboration, Risk Mitigation
Madison, Wisconsin, United States · On-site
Make a meaningful difference to patients around the world. As a part of the Field Clinical Specialist team, you will be a critical part of delivering our patient focused innovations, partnering with clinical professional…
Skills: Device Handling, Clinical Training, Interventional Cardiology, Cardiac Sonography, Multiplanar Reconstruction
Limerick, Munster, Ireland · On-site
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 …
Skills: Six Sigma, Lean Manufacturing, CAD, Project Management, Statistical Techniques
Ciudad de México, Mexico · On-site
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in …
Skills: Regulatory Affairs, Regulatory Submissions, Medical Device Regulations, Project Management, Technical Writing
Cartago, Costa Rica · On-site
Marca una diferencia significativa para los pacientes de todo el mundo. En las instalaciones de Edwards Lifesciences en todo el mundo, nuestros equipos de fabricación crean las herramientas, tecnologías y dispositivos qu…
Skills: Sewing, Hand-Eye Coordination, Microscope Operation, GMP, Clean Room Protocols
Cartago, Costa Rica · On-site
Applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines. Key Responsibilities: • Use tools – needles, scissors, for…
Skills: Sewing, Hand-eye Coordination, GMP, Clean Room Operations, Medical Device Assembly
Irvine, California, United States · On-site
$92k–$130k/yr
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments…
Skills: Regulatory Affairs, Product Submissions, Compliance, Medical Device Regulations, Technical Documentation
Moncada, Valencian Community, Spain · On-site
Make a meaningful difference to patients around the world. Our talented people are central to the future of Edwards Lifesciences, which is why our Human Resources teams help design, guide, and deliver inspiring experienc…
Skills: People Management, Strategic HR Planning, Talent Development, Succession Planning, Employee Relations
Draper, Utah, United States • On-site
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
This role focuses on supporting production operations and precision machining through the investigation of quality issues, managing NCRs and CAPAs, and overseeing product release. The engineer will optimize manufacturing processes using Six Sigma and Lean methods while ensuring successful product transfers and compliance with regulatory standards.
Requires a Bachelor's degree in engineering or science with 2 years of experience in a regulated manufacturing environment, or a Master's degree. Candidates must have proven experience owning nonconforming material investigations (NCRs) and corrective and preventive actions (CAPAs).
This Quality Engineer II is a hands-on quality engineering role supporting production operations, process controls, inspection systems, and manufacturing quality improvements within Edwards' precision machining operations. This position partners closely with Manufacturing Engineering, Operations, and New Product Introduction teams to ensure product quality, process stability, and successful product transfers into commercial production.
The ideal candidate brings experience owning nonconforming material investigations, CAPAs, manufacturing quality systems, process validation activities, and production line support within a regulated manufacturing environment. Experience supporting machine operations, MES systems, and continuous improvement initiatives is highly desirable.
Investigate moderately complex manufacturing product quality and compliance issues which may include:
Investigating 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; analyze results,
Provide technical support to external and internal audits,
Make recommendations and develop reports.
Oversee product release, assess and disposition product on hold (MRB), and manage material quality control.
Review and approve equipment validations and asset management actions.
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
Collaborate with engineering teams to ensure successful transfers
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.
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Provides support for 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
Bachelor’s degree in engineering or a scientific field with 2 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or related experience in a regulated manufacturing environment; OR
Master’s degree in engineering or scientific field with no experience (or internship/co-op experience)
Experience owning NCRs and CAPAs
Engineering degree
Highly regulated manufacturing environment experience (medical device highly preferred)
Experience supporting manufacturing operations, production processes, or sustaining engineering activities.
Experience investigating and resolving quality issues through structured problem-solving methodologies.
Strong understanding of MRB processes, quality metrics, and continuous improvement methodologies.
Familiarity with Manufacturing Execution Systems (MES).
Hands-on involvement with precision machining environments, including CNC and Swiss machining operations.
Proficiency with Keyence inspection systems, vision systems, or automated inspection technologies.
Background supporting new product introduction (NPI), manufacturing transfers, product launches, and production stabilization.
Working knowledge of process validation activities, including IQ/OQ/PQ and manufacturing process controls.
Understanding of SPC, pFMEA, risk management, root cause analysis, and statistical problem-solving techniques.
Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement tools.
Demonstrated ability to collaborate effectively with Operations, Manufacturing Engineering, Quality Control, and cross-functional stakeholders.
Familiarity with FDA Quality System Regulations, ISO 13485, and regulated manufacturing quality systems.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), 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. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), 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. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
