Irvine, California, United States · On-site
$108k–$153k/yr
Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technolog…
Skills: Manufacturing Engineering, Process Validation, IQ/OQ/PQ, Six Sigma, Lean Manufacturing
Colorado, United States · Remote OK
$74k–$104k/yr
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, li…
Skills: 3D Computed Tomography Analysis, Cardiac Image Acquisition, CT Reconstruction, Clinical Evaluation, Stakeholder Training
Irvine, California, United States · On-site
$139k–$196k/yr
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: Catheter Design, Creo/ProE, SolidWorks, Design Control, Prototype Iteration
Shanghai, Shanghai, China · On-site
The role is responsible for the development and execution of Market Access and Government Affairs strategies. The individual will work in close collaboration with local Business leaders and will implement and execute and…
Skills: Market Access Strategy, Government Affairs, Health Economics, Pricing & Reimbursement, Stakeholder Management
Irvine, California, United States · On-site
$121k–$171k/yr
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: Electrical Hardware Design, RF Devices, Project Management, People Management, Design Control
Draper, Utah, United States · On-site
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 standard…
Skills: Visual Inspection, Dimensional Inspection, Functional Testing, Microscope Operation, SOP Adherence
Irvine, California, United States · On-site
$87k–$123k/yr
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: Root Cause Investigation, Design Control, Risk Management, Verification and Validation, Change Control
Irvine, California, United States · On-site
$159k–$226k/yr
Director, Strategic Marketing TMTT Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business uni…
Skills: Strategic Marketing, Product Lifecycle Management, Upstream Marketing, Voice-of-Customer, People Management
Irvine, California, United States · Hybrid
$121k–$171k/yr
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, li…
Skills: Data Analysis, Business Intelligence, Snowflake, Power BI, SQL
Irvine, California, United States · On-site
$87k–$123k/yr
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 standard…
Skills: Quality Engineering, CAPA, Six Sigma, Lean Manufacturing, Risk Management
Tel Aviv, Tel-Aviv District, Israel · On-site
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative …
Skills: People Management, Clinical Sales, Strategic Planning, Stakeholder Management, Coaching
Irvine, California, United States · On-site
$121k–$171k/yr
Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many …
Skills: Manufacturing Technology Development, Design for Manufacturability, Six Sigma, Lean Manufacturing, cGMP
Alton, Illinois, United States · On-site
$59k–$83k/yr
Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many …
Skills: Polymer Processing, Formulation Development, Coatings, FTIR, GPC
Moncada, Valencian Community, Spain · 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: Lean Methods, Basic Statistics, Process Validation, CAPA, Project Management
Valencia, Valencian Community, Spain · On-site
Make a meaningful difference to patients around the world. Our Internship Program is designed to help early-career professionals contribute to solutions that transform patient lives. We believe in investing in the future…
Skills: Construction Coordination, Technical Documentation Review, Project Delivery, Contractor Monitoring, Defect Resolution
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
JAPAC Business Solutions is part of the JAPAC Business Operations team. The primary focus is on enhancing business processes and driving sales operational excellence across the JAPAC region. The team is involved in: · Op…
Skills: CRM Data Management, Data Cleansing, Salesforce, Salesforce Data Loader, Microsoft Excel
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
A Data Governance department ensures that an Edwards’s data is accurate, complete, and used responsibly. We are responsible for Healthcare Practitioner Master, (HCP), Customer Master, Supplier Master, Employee Master & P…
Skills: Data Governance, Master Data Management, Data Cleansing, Data Validation, Process Improvement
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
Newbury, England, United Kingdom · Hybrid
Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease. With millions of patients served in over 100 countries, each team makes a meaningfu…
Skills: EHS Regulatory Compliance, ISO 14001, Risk Management, Project Management, Stakeholder Management
Prague, Prague, Czechia · Hybrid
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: Information Security GRC, Risk Assessment, Control Model Administration, Regulatory Compliance, Data Governance
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The role involves setting up distribution and servicing operations and transferring sensor manufacturing lines to Irvine. Responsibilities include qualifying manufacturing processes, managing new product introductions, and resolving compliance issues like CAPAs.
Requires a Bachelor's degree in Engineering or Science with at least 4 years of manufacturing experience in a highly regulated industry. Experience with Class II/III medical devices and Lean Six Sigma certification is preferred.
Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives.
The Senior Manufacturing Engineering role is a great opportunity to support the IHFM manufacturing team as we begin to set up operations in Irvine. In this role you will begin by setting up the distribution and servicing operations for one of our most recent acquisitions. Upon successful setup in Irvine, you will join the team responsible for transferring our first sensor manufacturing line to Irvine. You will also support the IHFM team by managing engineering activities such as new product introductions, stabilization activities, and commercial manufacturing.
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.
Bachelor’s degree in Engineering or Scientific with a minimum of 4 years of manufacturing engineering experience in a highly regulated industry.
Onsite required.
Must have ability to travel up to 10%.
Class II and Class III medical device manufacturing experience.
Lean Six Sigma certification.
Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).
Experience with Windchill PTC.
Proven expertise in usage of MS Office Suite.
Effective communication and project management skills.
Strong analytical, problem solving, and technical writing skills.
Ability to work well independently based on minimal guidance.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $108,000 to $153,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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
