Irvine, California, United States · On-site
$159k–$226k/yr
Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner c…
Skills: Technical Leadership, Manufacturing Engineering, Process Validation, Six Sigma, Lean Manufacturing
Hartford, Connecticut, United States · On-site
Job Description 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 pion…
Skills: Territory Management, Customer Engagement, Market Penetration, Clinical Support, Account 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: SQL, Power BI, ETL/ELT, Dataflow Gen2, DAX
Atlanta, Georgia, United States · On-site
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: Clinical Support, Patient Training, Troubleshooting, Data Analysis, Case Management
Irvine, California, United States · On-site
$68k–$96k/yr
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As …
Skills: Contract Negotiation, Contract Administration, Financial Tracking, Risk Mitigation, Redlining
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
Springfield, Illinois, United States · On-site
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, Clinical Imaging
Cartago, Costa Rica · On-site
Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-…
Skills: Cloud Security Architecture, AI Security, AWS, Azure, LLM Security
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
Shanghai, Shanghai, China · On-site
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to…
Skills: Commercial Strategy, Sales Leadership, Market Trend Analysis, Executive Negotiation, Medical Device Industry Knowledge
France · Hybrid
BU – Transcatheter Heart Valve (THV) Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replaceme…
Skills: Clinical Education, Interventional Cardiology, Device Implantation, Troubleshooting, KOL Management
Holtsville, New York, 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: Valve Crimping, Case Management, Pre-case Planning, Clinical Education, Interventional Cardiology
Boston, Massachusetts, 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 Observation
Irvine, California, United States · On-site
$81k–$116k/yr
Imagine how your ideas and expertise can change a patient’s life. Patients are at the heart of what we do at Edwards Lifesciences. Our Finance teams work hard to optimize our current and long-term success and enable our …
Skills: Financial Planning And Analysis, Budgeting, Forecasting, Variance Analysis, Financial Modeling
Nyon, Vaud, Switzerland · On-site
Senior Finance Manager for the Global Planning, Sourcing and Logistics (GPS&L) and Quality to lead the EMEA, Canada and LATAM region How you’ll make an impact: Business Partnership: Serve as a key strategic finance partn…
Skills: Financial Planning, Analysis, Reporting, Business Partnership, Financial Modeling
pune, Maharashtra, India · On-site
Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working …
Skills: Microsoft Power Platform, UiPath, Power Automate, Power Apps, Dataverse
Irvine, California, United States · On-site
$126k–$178k/yr
Innovation starts from the heart. Heart failure impacts millions of lives globally. As communities address the opportunities and challenges of heart failure management, telling a compelling and authentic story about our …
Skills: Product Marketing, Sales, Healthcare, Cross-Functional Collaboration, Communication
Seattle, Washington, 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 Observation
Irvine, California, United States · Hybrid
$139k–$196k/yr
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: Workday Configuration, HRIS Strategy, Project Management, Solution Design, Stakeholder Management
pune, Maharashtra, India · On-site
Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working …
Skills: Microsoft Power Platform, UiPath, Power Automate, Power Apps, Dataverse
Irvine, California, United States • On-site
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Lead a team of manufacturing engineers to develop, qualify, and transfer processes for commercializing new surgical medical devices. Act as a primary liaison between R&D, supply chain, and quality to ensure seamless product launch and operational stability.
Requires a Bachelor's degree in engineering or science with at least 12 years of experience, including 5 years of people leadership in the medical device industry. Must have expertise in product development, process validation, and the ability to travel up to 25%.
Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
Provide technical leadership and manage a team of manufacturing engineers to lead the development, qualification, and transfer of manufacturing processes to successfully commercialize new products in the Surgical Business Unit.
Advance engineering activities from early product development through product launch while ensuring that manufacturing processes are developed that fully meet the operational needs for commercial success.
Act as a liaison between R&D, supplier development, Global Supply Chain (GSC), quality, and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.
Partner with New Product Introduction Managers, Pilot and Sustaining Operations, and Edwards manufacturing global locations to ensure successful outcomes towards the development, scaleup and transfer of manufacturing operations including the development of harmonized validations strategies and attainment of stability metrics. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
Provide technical leadership for the Surgical business unit’s manufacturing engineering (ME) team for successful process development, design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN, cGMP, EH&S guidelines, supplier development and process validation.
Manage/oversee the work direct reports within own function and/or cross functional project teams. Support the development of PMOs and individual development plans (IDPs) for the team. Develop a robust talent development plan in alignment with functional growth strategies of the individual and the department.
Plan and manage project activities (e.g., VIP/value engineering, COGS reduction activities, process improvement, etc.) with accountability for successful completion of all deliverables to the business. Where appropriate develop project plans, schedule, scope, and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods).
Bachelor's Degree in engineering or scientific discipline.
Manufacturing operations experience with five of those years in the product development process and introduction of new products into supply chain in the medical device industry.
Experience in preparing for and presenting project status to executive leadership, including the development, and managing of dashboards.
Willingness to travel up to 25%, both domestically and internationally, as required to support business and manufacturing needs.
On‑site presence required to effectively lead teams, collaborate cross‑functionally, and support manufacturing operations.
Advanced engineering degree and/or Six Sigma Black Belt certification.
Experience in the medical device industry.
12 years of experience with 5 years of people leadership experience.
Knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: implantable NiTi, CoCr & tissue, mechanical devices, catheter-based delivery system.
Ability to set clear expectations and orchestrate all Operations activities related to planning, sourcing, manufacturing, distribution, and associated functions.
Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines, and financial acumen as it relates to engineering.
Strong collaborator and communicator with a high degree of emotional intelligence and the ability to understand business partner needs and manage satisfaction relative to deliverables.
Experience in organizational change management possessing skills and ability to influence stakeholders, manage and socialize expectations, understand trade-offs and their impact, and mobilize cross functional teams to make effective business and patient focused decisions.
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 $159,000 to $226,000 (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
