Irvine, California, United States · On-site
$139k–$196k/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: Design for Manufacturability, Process Validation, Risk Management, PFMEA, Electrical Engineering
Beijing, Beijing, China · On-site
Job Description Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD organization i…
Skills: Hemodynamic Monitoring, Cardiovascular Anatomy, Sales Strategy, Relationship Management, Business Development
São Paulo, São Paulo, Brazil · On-site
Oportunidade para atuar na equipe de Business Operations da Edwards, especificamente na área de Licitações Públicas, e aprender sobre o universo de compras da Administração Pública no mercado de saúde no Brasil; Atividad…
Skills: Public Procurement Laws, Office Package, Interpersonal Skills, Organization, English
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: Incident Response, Detection Engineering, Threat Hunting, SIEM, SOAR
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: SIEM Engineering, SOAR Operations, Data Pipeline Management, Log Ingestion, Parser Development
Singapore, Singapore · 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 (e.g. needles, scissors,…
Skills: Sewing, Manual Dexterity, Hand-Eye Coordination, GMP, Clean Room Operations
Singapore, Singapore · 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: Medical Device Sales, Relationship Management, Structural Heart Therapies, Clinical Expertise, Market Share Expansion
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: TIBCO BusinessWorks 6, Linux OS, TIBCO Enterprise Message Service, TIBCO TEA, TIBCO HAWK
Singapore, Singapore, Singapore · On-site
Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed. Key Responsibilities: • Perform visual, dimensional, and funct…
Skills: Visual Inspection, Dimensional Inspection, Functional Testing, Quality Management System, Device History Records Review
Singapore, Singapore · 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: Sterile Packaging, Labeling, GMP, Clean Room Operations, JDE Transactions
Caesarea, Haifa District, Israel · On-site
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: Machine Learning, Algorithm Development, MLOps, Signal Processing, Control Systems
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: SOAR Architecture, Python, API Integration, Incident Response Automation, AI Agent Frameworks
Cartago, Costa Rica · On-site
The patients we serve are at the heart of Edwards Lifesciences’ culture. We help our teams achieve this mission by building safe, clean, and innovative workspaces so our people can feel effective with their work. As part…
Skills: Carpentry, Plumbing, Painting, HVAC Maintenance, Electrical Systems
Binghamton, 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: Clinical Training, Case Management, Pre-case Planning, Valve Crimping, Interventional Cardiology
Irvine, California, United States · On-site
$87k–$123k/yr
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: Clinical Development, CAD, Statistical Techniques, Clinical Imaging, Medical Device Design
Irvine, California, United States · On-site
$121k–$171k/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: Statistical Analysis, Project Management, Test Method Validation, IQ/OQ/PQ, GD&T
Irvine, California, United States · On-site
$121k–$171k/yr
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: Project Management, IT Project Lifecycle, Risk Management, Financial Management, Stakeholder Management
Chicago, Illinois, United States · On-site
$134k–$190k/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: Clinical Trial Support, Patient Education, Device Handling, Case Documentation, Clinical Monitoring
São Paulo, São Paulo, Brazil · On-site
Trust is key to fostering the positive change required to impact patient lives for the better. Honoring and safeguarding Edwards’ reputation and brand identity, our Public Affairs teams build and maintain valued partners…
Skills: Health Economics, Outcomes Research, Cost-effectiveness Modelling, Budget Impact Model, Value Proposition Development
Harar, Harar, Ethiopia · On-site
Develops clinical education materials in connection with clinical investigations including providing education and clinical insights on the device, procedure and protocol throughout the life cycle of the clinical investi…
Skills: Clinical Education, Device Implantation, Cardiovascular Science, Imaging Analysis Software, Medical Device Regulatory Requirements
Irvine, California, United States • On-site
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Lead the transition of sensor-integrated medical devices from design into commercial production by developing manufacturing processes and test systems. Responsible for ensuring electronic medical devices meet global safety and performance standards through DFM, process validation, and risk management.
Requires a Bachelor's, Master's, or PhD in Electrical, Manufacturing, or Mechanical Engineering with 4 to 8+ years of experience. Preferred expertise includes knowledge of IEC 60601 standards, ISO 13485, and FDA quality systems.
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 Sr. Principal, Engineer, NPD position is a unique career opportunity that could be your next step towards an exciting future.
Join our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit as a Sr. Principal NPD Engineer to boldly pursue an innovative portfolio of technologies for patients with complex heart valve disease. We are seeking a Sr. Principal NPD Engineer to lead the transition of advanced, sensor-integrated medical devices from design into Commercial production. This role is a key leadership position within our New Product Development (NPD) team, responsible for developing the manufacturing processes, test systems, and production specifications that ensure our electronic medical devices meet global safety and performance standards from Day one.
How you’ll make an impact:
Design for Manufacturability (DFM): Act as the lead manufacturing voice in R&D design reviews, ensuring that sensor architectures and electronic assemblies are optimized for cost-effective, high-yield production.
Manufacturing Test Strategy: Develop and implement end-of-line production testing for safety and functionality, specifically overseeing:
Hipot & Leakage Current Testing: Validating production-level insulation and safety under normal and single-fault conditions.
EMC Assurance: Ensuring manufacturing processes (such as cable routing or shielding assembly) do not compromise the device’s IEC 60601-1-2 compliance.
Specifications & Drawings: Develop detailed manufacturing specifications & Instructions, Bill of Materials (BOM), and assembly drawings. Partner with R&D to define critical-to-quality (CTQ) dimensions and tolerances for sensors and electronics.
Process Validation (IQ/OQ/PQ): Lead the strategy and execution of Installation, Operational, and Performance Qualifications for new assembly lines and automated sensor calibration equipment.
Vendor & Supply Chain Management: Interface with external electronic manufacturing services (EMS) and sensor suppliers to establish quality agreements and technical requirements for sub-assemblies.
Risk Management: Author and maintain Process Failure Mode and Effects Analysis (PFMEA) to mitigate risks in the manufacturing of safety-critical electronic systems.
Own device system end to end of new product development; Start thinking strategically about new product development.
Lead strategy, prioritization, and technical support for QST, pre DV, DV – SME to Pilot on root cause investigations for manufacturing processes (prior to commercialization)
Experience developing production-level test fixtures and tooling.
Hands-on experience with Hipot testers, leakage current meters, and spectrum analyzers.
Assure drawing review processes and take responsibility for tolerance stack-up compliance.
Drive specifications from an operations perspective (i.e., DFx, tolerancing, material selection, automation), define the establishment of stability metrics, and elevate/mitigate risks through SCRR and MRR.
Use voice of the Factory and SME product knowledge to drive improvements and standardization.
Serve as team lead in the analysis of basic Manufacturing and Compliance issues (e.g., CAPA, non-conformance, audit observations) and provide technical support in process transfer.
Identify opportunities for redesign/design of basic equipment, tools, fixtures, etc., to improve manufacturing processes through all design phases; drive and execute opportunities in collaboration with R&D and manufacturing organizations (Pilot or Commercial).
Support commercial redesign opportunities and notifications of change from suppliers based on design intent of the device.
Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement and support stability metrics through design phases.
Follow project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Oversee manufacturing support tasks; supervise technicians and/or lower-level engineers.
Perform other incidental duties.
What you’ll need (Required):
Bachelor's Degree Electrical, Manufacturing, or Mechanical Engineering. with minimum of 8 years of experience, including either industry or industry/education Required or
Master's Degree Electrical, Manufacturing, or Mechanical Engineering with minimum of 7 years of experience, including either industry or industry/education Required or
Ph.D. or equivalent Electrical, Manufacturing, or Mechanical Engineering with minimum of 4 years of experience, including either industry or industry/education Required
What else we look for (Preferred):
Strong working knowledge of IEC 60601-1 and IEC 60601-2 from a production verification standpoint.
Proficiency in ISO 13485 Quality Management Systems and FDA 21 CFR 820.
Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines
Advanced problem-solving, organizational, analytical and critical thinking skills
Strong leadership skills and ability to influence change
Works on unusually complex technical problems requiring highly innovative and creative solutions.
Interprets internal and external business issues and recommends best practices.
Anticipates potential challenges and proactively seeks novel approaches to resolution.
Guides the successful completion of major programs and may function in a project leadership role
Contributes to strategic project direction
Ensures that technologies are up-to-date and looking ahead
Identifies technical gaps and takes action to address them
Interacts with senior external representatives on significant technical matters often requiring coordination between organizations
Proven expertise in usage of MS Office Suite; CAD experience preferred
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate complex and technical information to all levels of the organizations
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 $139,000 to $196,000 (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
