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Edwards Lifesciences

Edwards Lifesciences is a leading global company focused on innovative solutions for structural heart disease. They specialize in transcatheter heart valves, surgical valve technologies, and implantable heart failure management. Committed to improving patient lives, Edwards Lifesciences also engages in clinical research and provides resources for healthcare professionals. The company emphasizes a culture of innovation and inclusion, offering diverse career opportunities across various fields.

<div>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&rsquo;s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Senior Manager, Product Cath Lab (IHFM) will lead upstream marketing activities for all cath lab products and processes. This is an exciting opportunity for a strong marketing professional with prior medical device experience to lead upstream marketing initiatives for key products of the Cordella Pulmonary Artery (PA) Sensor and Heart Failure System.
The Senior Manager is responsible for capturing and translating voice-of-customer insights, defining product requirements and partnering closely with a cross-functional team throughout the product development lifecycle. The ideal candidate is capable of building robust product roadmaps that connect to strategic priorities across global regions.
This role requires onsite presence at our corporate headquarters in Irvine, CA.
How you will make an impact:
<ul><li>Develop and drive the execution of comprehensive product strategies for Cordella cath lab products, spanning both hardware and software.
</li><li>Create and execute marketing plans&mdash;including strategies and tactics&mdash;across multiple major product launches, programs, and initiatives.
</li><li>Build relationships with key opinion leaders (KOLs) to inform the product roadmap and launch plans, and to stay current on the market environment and competition
</li><li>Maintain a comprehensive library of customer needs spanning internal and external stakeholders as the business grows.
</li><li>Craft marketing messages grounded in regional strategies, current literature, the competitive environment, and regulatory/legal requirements across these major launches and programs.
</li><li>Produce product materials and programs that support launch and commercialization strategies for those initiatives.
</li><li>Guide marketing collateral and labeling through all relevant legal and regulatory approval processes, partnering with cross-functional stakeholders.
</li><li>Orchestrate the execution of major launches in collaboration with regional partners as appropriate, including sales force readiness (e.g., training on product, messaging, and competition).
</li><li>Refine and expand a body of clinical and economic evidence that supports the regional value proposition.
</li><li>Manage budgets across the product line, campaigns, and projects
</li><li>Analyze clinical and market data to assess the regional impact of potential product launches.
</li><li>Champion significant process or corporate initiatives that bring value to the marketing organization.
</li></ul>What you will need (Required):
<ul><li>Bachelor's Degree or Equivalent in related field, 10 years&rsquo; experience of previous related experience working in marketing or healthcare industry or equivalent work experience based on Edwards criteria.
</li></ul>What else we look for (Preferred):
<ul><li>Master's Degree or equivalent in related field, 8 years experience of previous related experience working in marketing or healthcare industry or equivalent work experience based on Edwards criteria.
</li><li>Proven successful project management skills.
</li><li>Proven expertise in Microsoft Office Suite.
</li><li>Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
</li><li>Recognized as an expert in own area with specialized depth within the organization.
</li><li>Expert understanding of related aspects of marketing concepts and principles.
</li><li>Extensive understanding of broad market research designs, develops market research programs coordinating with the global VOC manager and demonstrates an in-depth understanding of commercial goals behind research.
</li><li>Ability to forecast product lines for short-term and long-term accuracy based on market development, sales trends, competition and changing market dynamics.
</li><li>Ability to assess and understand market share, pricing, ASPs, competitive dynamics.
</li><li>Possess strong clinical knowledge, experience and knowledge of the clinical areas where Edwards' products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks.
</li><li>Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
</li><li>Ability to manage competing priorities in a fast paced environment.
</li><li>Represents leadership on projects within a specific working closely with cross-functional team, marketing peers and leaders and managing needs and messaging to upper management.
</li><li>Consult in project setting within specific marketing area.
</li></ul>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 $145,000 to $205,000 (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.
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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.</div>

Senior Manager, Product Cath Lab IHFM

<div>Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) business's AI, Product and Platforms organization, 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 is our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
At Edwards Lifesciences, the IHFM AI, Product and Platforms organization designs and builds the software and data products that clinicians and patients depend on. As a Principal Data Engineer, you define data architecture and strategy across multiple product areas and serve as a primary technical authority for the data platform.
How you'll make an impact
<ul><li>Define the data architecture and platform strategy across multiple IHFM product areas.
</li><li>Lead the most complex and ambiguous data engineering problems, including suite-level interoperability and device-data scale.
</li><li>Influence the roadmap with Technical Data Product Managers and Data Intelligence and Engineering leadership.
</li><li>Set the standards for ingestion, modeling, governance, lineage, quality, data products, data contracts, and SLAs that the data platform runs on.
</li><li>Establish how validated, traceable, and integrity-preserving data pipelines are engineered across the platform.
</li></ul>What you'll need (Required):
<ul><li>Bachelor's degree in engineering or scientific field plus six or more years of related data engineering experience.
</li><li>Recognized experience in data platform architecture, distributed processing, and large-scale data modeling, including modern data platforms such as Databricks and Snowflake.
</li><li>Deep experience with data governance, validation, and integrity in a regulated environment.
</li></ul>What else we look for (Preferred):
<ul><li>Experience defining multi-area data architecture across cloud providers, such as GCP and AWS.
</li><li>A track record of setting technical direction adopted across multiple product areas.
</li><li>Excellent communication skills, including senior product development leadership.
</li><li>Experience across the breadth of the modern data ecosystem, such as Apache Spark, Kafka, Flink, Delta Lake, Iceberg, Airflow, and dbt.
</li><li>Deep experience with healthcare interoperability (HL7, FHIR, IHE) and device telemetry at scale.
</li><li>A history of influencing data platform strategy in regulated software or other regulated classes of device software.
</li></ul>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 $121,000 - $171,000 (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.
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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.</div>

Principal Data Engineer, R&D

<div>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 in close partnership with teams across regions to deliver reliable, high-quality solutions at scale.
<div><div><div><div><div><div><div><div><div>Designed as a long-term investment, the Pune Hub will advance newer digital capabilities such as automation, data, AI, and cloud, and will include roles spanning end user services, application development, and enterprise platform teams.
</div></div></div></div></div></div></div></div></div>How will you make an impact:
CI/CD &amp; Platform Engineering
&middot; Build and maintain CI/CD pipelines (Azure DevOps / GitHub Actions / Jenkins)
&middot; Manage secrets, configurations, variables, and environment parameters
&middot; Implement reusable pipeline templates for consistency and scalability
&middot; Support unattended, scheduled, and triggered execution workflows
Execution Grid &amp; Infrastructure
&middot; Provision and operate execution grids (cloud and/or on‑prem)
&middot; Balance cost, performance, and scalability trade‑offs
&middot; Optimize execution runtime through parallelization and sharding strategies
&middot; Ensure high availability and platform reliability
Observability &amp; Reliability Engineering
&middot; Implement logging, metrics, and alerting for automation execution
&middot; Integrate execution data into dashboards and reporting views
&middot; Reduce automation flakiness using engineering‑led controls
&middot; Monitor trends and proactively improve execution stability
Evidence, Reporting &amp; Data Orchestration
&middot; Integrate automation results with dashboards and reporting systems
&middot; Automate evidence capture and apply retention policies
&middot; Partner with Test Data Engineer to orchestrate pre‑run and post‑run data jobs
&middot; Support traceability, audit readiness, and compliance needs
What you'll need (Required):
&middot; 4 to 6 years of experience in DevOps, SDET, or Automation Platform roles
&middot; Strong hands‑on experience with CI/CD pipelines and infrastructure
&middot; Proficiency in scripting (Bash, Python, PowerShell)
&middot; Experience managing environments, configurations, and automation execution infrastructure
What else we look for:
&middot; Experience with containers and orchestration platforms
&middot; Exposure to cloud‑based runners and execution infrastructure
&middot; Hands‑on experience with observability stacks (e.g., App Insights, ELK, Grafana)
&middot; Understanding of security controls , secrets management, and compliance practices
Core Competencies
&middot; CI/CD Engineering
&middot; Infrastructure‑as‑Code mindset
&middot; Observability &amp; Monitoring
&middot; Reliability Engineering
&middot; Collaboration &amp; Cross‑team Enablement
Collaboration &amp; Reporting
&middot; Works closely with Test Automation Manager (TAM)
&middot; Collaborates with pod leads, Test Data Engineer , and platform/infra/security teams
&middot; Acts as a platform enabler for automation delivery teams
Recruiting scam alert: Read our notice about potential recruiting scams.</div>

Engineer, CI/CD & Automation Platform

<div>Innovation starts from the heart. Our Advanced Innovation &amp; Technology (AI&amp;T) teams harness the imagination, courage, and resourcefulness to think beyond what&rsquo;s currently possible, and create solutions for patients many years into the future. If you&rsquo;re an early-stage innovator, then Edwards AI&amp;T team is the place for you to take the next steps in your career. We&rsquo;ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
<div></div><div><div><div><div><div>Imagine how your ideas and expertise can change a patient&rsquo;s life. Our Global Operations &amp; Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You&rsquo;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.
</div></div></div></div></div>How you'll make an impact:
<ul><li>Provide technical ownership for successful development of manufacturing technologies (processes) to seamlessly transition from Early Human Use (EHU) through all phases of Edwards&rsquo; Product Development Process (PDP) to meet the manufacturing and supply chain needs of the Business Unit.
</li><li>Champion design for manufacturability, design and process excellence, six sigma thinking, LEAN, cGMP, EH&amp;S requirements in executing process validations.
</li><li>Drive resource maximization while minimizing development expenditure.
</li><li>Work in close collaboration with cross functional partners and peers from Pilot Ops and extended GSC functions such as sourcing, supplier development, supplier quality etc., BU functions such as R&amp;D, PMO, Design Assurance (DA), Regulatory, to align on goals and drive action to meet commitments to the BU including product builds for R&amp;D evaluation, clinical studies, and downstream needs as assigned.
</li><li>Identify risks across manufacturing operations including those associated with or arising from technology, materials, skills/competencies, design requirements etc. and develop/implement mitigations to deliver successful outcomes for the business.
</li><li>Lead the development and implementation of tools/methodologies for effective problem-solving, failure analysis, root cause investigation and best practices for agile deployment of responses and robust solutions that deliver superior results that also elevate learning, critical thinking, and impact across the business.
</li><li>Drive build strategy, prioritization, and technical support for QST, pre DV, DV, OQ and PQ &ndash; Key Partner to Pilot on root cause investigations for manufacturing processes.
</li><li>Ensure development and implementation of robust characterization and validation activities in collaboration with partners from R&amp;D and quality, including deployment of critical control points (CCPs) in manufacturing.
</li><li>Prioritize the timely development of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
</li><li>Oversee the design and development of manufacturing tools, fixtures and equipment that provide the highest levels of quality and mistake proofing while meeting or exceeding requirements for reliability and robustness that meet Edwards' standards for tools and fixtures including EH&amp;S and ergonomic standards.
</li></ul>What you&rsquo;ll need (Required):
<ul><li>Bachelor&rsquo;s Degree in Engineering or Scientific field with 6 years of previously related industry experience OR
</li><li>Master&rsquo;s Degree in Engineering or Scientific field with 5 years of previously related industry experience OR
</li><li>Ph.D. in Engineering or Scientific Field with 2 years of previous related industry experience
</li></ul>What else we look for (Preferred):
<ul><li>Deep expertise in conceptualizing, designing, developing and successful implementation of manufacturing technologies for the assembly of complex devices.
</li><li>Comfort with CAD package and self-reliant on CAD usage for medium to high-complexity designs including GD&amp;T principles. Ability to review and trouble shoot engineering/component and assembly drawings, assess tolerancing and stack-ups, and application of industry standards such as ISO.
</li><li>Track record with developing highly capable, reliable and scalable technologies that are agile.
</li><li>Experience transferring manufacturing lines across sites/geographies and preparing tech transfer knowledge kit.
</li><li>Knowledge of design controls for Class II &amp; III medical devices, including familiarity with: catheter-based delivery system. implantable devices - NiTi, CoCr, and mechanical devices, polymeric materials, textiles, fabrics, etc. and associated technologies to inspect, join, attach, fabricate and integrate dissimilar materials.
</li><li>Strong collaborator and communicator with a high degree of emotional intelligence and the ability to understand business partner needs and manage expectations.
</li><li>Experience in preparing for and presenting project status to leadership, including the development, and managing of dashboards.
</li><li>Sound understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines.
</li><li>Ability to influence cross-functional partners, business units, and/or sites and interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
</li></ul>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 (CA), the base pay range for this position is $121,000 to $171,000 (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.
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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.</div>

Principal Engineer, NPD, Advanced Innovation and Technology

<div>Imagine how your ideas and expertise can change a patient&rsquo;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 standards of integrity and safety. You&rsquo;ll bring your passion for problem solving and partner with various teams to influence decision-making for a product&rsquo;s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. In this role, you will apply your 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.
<div>How you will make an impact:
 
<ul><li>Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
</li><li>Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma 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
</li><li>Develop, update, and maintain technical content of risk management files
</li><li>Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
</li><li>Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
</li><li>Other incidental duties assigned by Leadership
</li></ul></div><div>What you'll need (Required):
 
<ul><li>Bachelor's Degree in Engineering or Scientific field, 2 years&rsquo; experience related work experience or
</li><li>Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
</li></ul></div><div>What else we look for (Preferred):
 
<ul><li>Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
</li><li>Basic understanding of statistical techniques
</li><li>Previous experience working with lab/industrial equipment required
</li><li>Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
</li><li>Solid problem-solving, organizational, analytical and critical thinking skills
</li><li>Solid understanding of processes and equipment used in assigned work
</li><li>Knowledge of and adherence to Quality systems
</li><li>Strict attention to detail
</li><li>Ability to interact professionally with all organizational levels
</li><li>Ability to manage competing priorities in a fast paced environment
</li><li>Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
</li><li>Ability to build productive internal/external working relationships
</li><li>Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health &amp; 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
</li></ul></div>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 $87,000 - $123,000 (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.
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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.</div>

Pilot Quality Engineer II - Sheaths

<div>Imagine how your ideas and expertise in customer service can change a patient&rsquo;s life. At Edwards Lifesciences, our Customer Service teams are dedicated to providing thoughtful care and meaningful interactions to customers and stakeholders.
As a member of this team, you&rsquo;ll work cross-functionally across our organization to ensure our customers receive the support they need and feel connected to our mission of putting patients at the heart of every decision.
This role can be an onsite or hybrid role based at the Irvine, California corporate headquarters.
How you&rsquo;ll make an impact:
The Business Analyst helps hospital customers do business with Edwards more easily and efficiently, and helps advance Edwards Customer Service digital enablement, by facilitating accurate electronic ordering, supporting EDI capabilities, strengthening GHX connectivity and partnership processes, and driving process improvements that reduce manual effort and improve the overall ordering experience.
<ul><li>Assess business needs of assigned functional area; recommend improvements and streamline processes and data management related to EDI order intake, GHX transaction flows, hospital customer onboarding opportunities, inventory-related order fallout, and process improvements that increase electronic order volume.
</li></ul><ul><li>Develop functional business requirements and articulate system functionality and features. Translate the needs of business into functional requirement for EDI/GHX enhancements, hospital customer and trading partner setup, transaction mapping, order automation, exception handling, and reporting needs.
</li><li>Perform root cause analysis and troubleshoot business processes including testing and researching data integrity/accuracy to resolve EDI order failures, GHX transmission issues, data mismatches, inventory-related order fallout, order exceptions, and hospital customer setup issues that impact successful electronic order processing.
</li><li>Identify metrics and reports needed to measure process effectiveness and efficiencies including electronic order volume, manual-to-electronic conversion opportunities, exception rates, cycle time, hospital customer readiness, Sales Operations fallout trends, and GHX-related issue trends.
</li><li>Collaborate with team members in the development of training materials and materials for managing Organizational Change, streamlining transition and improving adoption when EDI workflows, GHX processes, electronic order procedures, or Sales Operations-facing processes change.
</li><li>Test and validate processes and systems to ensure adherence to functional requirements, including EDI transactions, GHX connectivity, hospital customer and trading partner setup, order routing, and system changes before implementation.
</li><li>Document process flows, business and functional requirements, use cases, test scripts/results and software validation documents Document process flows, business and functional requirements, use cases, test scripts/results, and software validation documents, including EDI workflows, GHX escalation paths, hospital customer onboarding steps, transaction requirements, troubleshooting guides, and knowledge management content.
</li><li>Collaborate with Customer Service leadership, CSRs, Sales Operations, IT, GHX, hospital customers, and their trading partners on process mapping and requirements gathering sessions
</li><li>Train users on new processes, workflows, and/or systems to promote adoption of electronic ordering, strengthen EDI exception handling, clarify when to engage GHX or internal support teams, and support a smoother ordering experience for hospital customers.
</li><li>Support continuous improvement initiatives that advance Customer Service digital enablement, reduce manual work, increase electronic order adoption, and improve the ease, accuracy, and efficiency of the hospital customer ordering experience.
</li></ul>What you&rsquo;ll need (Required):
<ul><li>Bachelor's Degree in a related field and 3 years of related experience in or equivalent work experience based on Edwards criteria
</li></ul>What else we look for (Preferred):
<ul><li>Experience supporting EDI transactions and electronic order intake in the healthcare industry, GHX processes, hospital customer and their trading partners onboarding, or healthcare order workflows
</li><li>Ability to use data to identify manual order trends, prioritize customer conversion opportunities, analyze Sales Operations fallout, and recommend actions that increase electronic order adoption
</li><li>Moderate understanding and knowledge of requirement solicitation, consulting practices, process mapping, project management principles, and software development lifecycle
</li><li>Ability to work in a team environment, including the ability to manage vendors and project stakeholders through GHX coordination, issue escalation, follow-up, and partnership on opportunities to improve EDI performance.
</li><li>Ability to build productive internal/external working relationships with internal stakeholders, Sales Operations, GHX, hospital customers, and their trading partners.
</li><li>Certification in enterprise applications platforms/tools such as ERP/order management systems, EDI platforms, GHX, Salesforce, reporting tools, or healthcare ordering technology
</li><li>Good computer skills in usage of MS Office Suite including related CRM tools and platforms
</li><li>Good problem-solving, organizational, analytical and critical thinking skills
</li><li>Strict attention to detail
</li><li>Good written and verbal communication skills and interpersonal relationship skills
</li><li>Ability to interact professionally with all organizational levels
</li><li>Ability to manage competing priorities in a fast-paced environment
</li><li>Ability to adapt to new technologies
</li><li>Ability to adapt to rapidly changing environment
</li><li>Adhere to all company rules and requirements, including Environmental Health &amp; Safety rules and applicable protocols.
</li></ul>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 (CA), the base pay range for this position is $68,000 to $96,000 (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.
#LI-Hybrid
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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.</div>

Business Analyst, EDI and Customer Service Operations

<div>Imagine how your ideas and expertise can change a patient&rsquo;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 standards of integrity and safety. You&rsquo;ll bring your passion for problem solving and partner with various teams to influence decision-making for a product&rsquo;s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
The Senior Software Quality Engineer is a key member of the Software Quality organization, responsible for ensuring the cybersecurity of product software including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), software as an accessory to a medical device, and other Digital Health Technologies. This role is responsible for owning and advancing product cybersecurity processes established within our Quality Management System and ensure alignment with applicable regulatory standards and industry guidance. The position will work in close partnership with R&amp;D, Product Security, Quality and other cross-functional team members to integrate cybersecurity requirements throughout the product software development lifecycle and support effective postmarket cybersecurity management.
We are seeking an ambitious, technically strong candidate with a solid foundation in quality and cybersecurity, excellent communication skills, and the ability to build trusted relationships across the organization. This role offers meaningful opportunities to grow within a dynamic and evolving Software Quality function.
How you will make an impact :
<ul><li>Own the establishment, implementation, and continuous improvement of cybersecurity related processes for product software established in our Quality Management System
</li><li>Review and approve product cybersecurity related deliverables across the lifecycle, including planning, requirements, architecture/design, risk management, verification and validation, and problem resolution (dispositioning of cybersecurity vulnerabilities and defects).
</li><li>Execute Cybersecurity risk analysis on our products.
</li><li>Provide assurance that all requirements related to cybersecurity are followed when developing or making changes to product software.
</li><li>Work in close partnership with Product Security, Quality and R&amp;D to address and monitor cybersecurity risks throughout the Product Software Development Lifecycle.
</li><li>Support regulatory submissions and responses regarding cybersecurity related requests.
</li><li>Effectively manage multiple priorities, projects and ability to communicate at all levels of personnel.
</li><li>Author, review and approve documents in our Application Lifecycle Management and Product Lifecycle Management systems.
</li><li>Willingness to work in a fast-paced, dynamic environment to meet the needs of the business and deliver safe quality products to our patients.
</li></ul>What you will need (Required):
<ul><li>Bachelor&rsquo;s degree in Scientific, Engineering, or Computer Science fields plus four (4) years of relevant work experience; OR Master&rsquo;s degree Scientific, Engineering, or Computer Science fields plus three (3) years of relevant work experience.
</li><li>Highly regulated industry experience
</li><li>Experience with software development and/or software quality in regulated environments
</li></ul>What else we look for (Preferred):
<ul><li>Engineering or Computer Science degree
</li><li>Medical device industry experience
</li><li>Experience with cybersecurity risk assessments
</li><li>Experience integrating cybersecurity into the SDLC / design controls
</li><li>Familiarity with vulnerability management and post market cybersecurity processes
</li><li>Familiarity with software (IEC 62304) and cybersecurity (NIST) guidelines; including understanding of Waterfall and Agile concepts in context with the SDLC process.
</li><li>Knowledge and experience in Medical Device Risk Management (ISO 14971)
</li><li>Excellent written and verbal communication skills required.
</li></ul>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 (CA), the base pay range for this position is $108,000 to $153,000 in tool (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.
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
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.</div>

Senior Software Quality Engineer - Cybersecurity

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