director, ed&t business partner, peripheral vascular division

principal engineer, npd, advanced innovation and technology

anesthesia technician - acc - irvine anesthesia - ft - variable shift

10607 – software engineer iii (data engineer)

ai engineer

director, ed&t business partner, peripheral vascular division Jobs in Irvine

principal data engineer, r&d Jobs in Irvine

principal data engineer, r&d

principal engineer, npd, advanced innovation and technology Jobs in Irvine

principal quality engineer Jobs in Irvine

principal quality engineer

principal engineer npd advanced innovation and technology

Edwards Lifesciences

<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

Medtronic

<div>We anticipate the application window for this opening will close on - 22 Jun 2026 
 
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
<h1 class="jobSectionHeader">A Day in the Life
</h1>At Medtronic, we act boldly, compete to win, move with speed, foster belonging, and deliver results&mdash;the right way. This is the Medtronic Mindset, defining how we work and what we value. Our brand is rooted in action, and every team member plays a vital role in bringing our culture to life.
 
 
We recognize your extraordinary potential to help ensure future generations live better, healthier lives. A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Supplier Quality Engineer based in Irvine, CA you will support the Neurovascular Operating Unit by ensuring externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. This role partners closely with Neurovascular R&amp;D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, and resolve supplier-related nonconformances that could impact product performance or patient safety. You will lead investigations and root cause analysis for supplier issues, drive corrective and preventive actions with suppliers, and monitor performance through robust metrics and reviews. By building strong technical relationships with key suppliers and championing continuous improvement, this role helps maintain reliable supply and high first-time quality for Neurovascular products manufactured in Irvine, CA.
 
 
Onsite: At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We&rsquo;re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 
Responsibilities may include the following and other duties may be assigned:
<ul><li>Ensures that suppliers deliver quality parts, materials, and services.
</li><li>Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
</li><li>Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
</li><li>Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
</li><li>Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
</li><li>Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
</li><li>Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
</li><li>Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
</li><li>Lead qualification and onboarding of new suppliers, including quality assessments, audits, and documentation review.
</li><li>Support risk management activities related to supplied materials and processes.
</li><li>Partners with Site R&amp;D, Quality, and Manufacturing Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
</li><li>Lead investigations for supplier-related nonconforming material and complaints; perform root cause analysis and implement sustainable corrective actions
</li></ul>Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile .
<ul><li>Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
</li></ul>Nice to Have
<ul><li>Experience working with medical device or highly regulated industries (FDA, ISO 13485, MDR, etc.)
</li><li>ASQ certifications such as Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or Certified Six Sigma Black/Green Belt
</li><li>Experience with supplier development and supplier performance improvement programs
</li><li>Demonstrated success in leading supplier audits (process, quality system, or compliance audits)
</li><li>Familiarity with risk management methodologies such as ISO 14971 and FMEA
</li><li>Experience supporting new product development (NPD) or design transfer to suppliers
</li><li>Strong background in advanced quality tools (SPC, MSA, DOE, capability analysis)
</li><li>Experience implementing or improving supplier corrective action (SCAR/CAPA) systems
</li><li>Experience working with contract manufacturers and global supply chains
</li><li>Exposure to manufacturing process validation (IQ/OQ/PQ) at supplier sites
</li><li>Experience with APQP, PPAP, and control plan development
</li><li>Familiarity with digital quality systems such as TrackWise, MasterControl, SAP, or similar QMS platforms
</li><li>Experience with component or process qualification for complex technologies (electronics, polymers, machining, sterile processing, etc.)
</li><li>Ability to analyze supplier quality metrics and drive continuous improvement initiatives
</li><li>Experience influencing suppliers and cross-functional teams without direct authority
</li><li>International supplier engagement experience or willingness to travel for supplier support and audits.
</li></ul>For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. &sect; 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization &amp; Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life&mdash;where your unique background and perspective are valued.
<h1 class="jobSectionHeader">Benefits &amp; Compensation 
 
</h1>Medtronic offers a competitive Salary and flexible Benefits Package
 
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. 
 
Salary ranges for U.S (excl. PR) locations (USD):$99,200.00 - $148,800.00 
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program). 
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). 
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. 
Further details are available at the link below:
Medtronic benefits and compensation plans
<h1 class="jobSectionHeader">About Medtronic
</h1>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
 
Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
 
We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
<div><div><div><div><div><div><div>If you are applying to perform work for Medtronic, Inc. (&ldquo;Medtronic&rdquo;) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.</div></div></div></div></div></div></div></div>

Senior Supplier Quality Engineer

<div>We anticipate the application window for this opening will close on - 22 Jun 2026 
 
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
<h1 class="jobSectionHeader">A Day in the Life
</h1>Join our Supply Chain team as an Inventory Analyst supporting our OC Campus and play a key role in keeping our materials and products flowing smoothly from raw components to finished goods. In this role, you&rsquo;ll lead inventory management initiatives to achieve our inventory targets, and partner closely with operations, purchasing, logistics, and planning. You&rsquo;ll help design and maintain the processes, controls, and material management systems that reduce costs, streamline workflows, and ensure we always have the right materials in the right place at the right time.
 
 
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results&hellip;the right way. That&rsquo;s the Medtronic Mindset &mdash; our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. 
Responsibilities may include the following and other duties may be assigned:
<ul><li>Ensures that inventories are secure, properly identified and readily accessible to authorized personnel.
</li><li>Maintains controls over various types of inventories (e.g., raw materials, subassemblies, finished goods).
</li><li>Conducts physical inventory counts and reconciles results with inventory records.
</li><li>Ensures that quantities of incoming and outgoing shipments are correct.
</li><li>Conducts analyses of inventory levels and coordinates with production and supply network planning requirements.
</li><li>Creates integrated processes among internal functions (e.g., operations, purchasing and logistics).
</li><li>Plans and analyzes activities related to the timely, cost-effective procurement, inventory control, planning and quality control of production materials.
</li><li>Develops, implements, and maintains policies, procedures, and material control systems to reduce costs, streamline procedures, and implement solutions.
</li></ul>At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We&rsquo;re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and resume
<ul><li>Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
</li><li>Requires a bachelor&rsquo;s degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. &sect; 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
</li></ul>Preferred:
<ul><li>CPIM (Apics certification)
</li><li>SAP
 </li><li>Advanced Excel
</li><li>Strong communication skills (both verbally and in written) with a proven ability to understand key concepts and communicate with business stakeholders
 </li><li>Excellent mathematics/analytics/statistical skills demonstrated through education or professional background
</li></ul>For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. &sect; 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization &amp; Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life&mdash;where your unique background and perspective are valued.
<h1 class="jobSectionHeader">Benefits &amp; Compensation 
 
</h1>Medtronic offers a competitive Salary and flexible Benefits Package
 
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. 
 
Salary ranges for U.S (excl. PR) locations (USD):$67,200.00 - $100,800.00 
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program). 
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). 
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. 
Further details are available at the link below:
Medtronic benefits and compensation plans
<h1 class="jobSectionHeader">About Medtronic
</h1>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
 
Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
 
We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
<div><div><div><div><div><div><div>If you are applying to perform work for Medtronic, Inc. (&ldquo;Medtronic&rdquo;) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.</div></div></div></div></div></div></div></div>

Inventory Analyst

Katalyst Healthcares & Life Sciences

<div>Job Description: 
We are seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives in a regulated manufacturing environment. This role provides technical leadership for quality systems, product quality improvements, risk management, CAPA activities, process validation, and compliance programs. The Principal Quality Engineer serves as a subject matter expert, partnering with cross-functional teams to ensure products meet customer, regulatory, and business requirements while driving continuous improvement and operational excellence. 
Responsibilities:
<ul><li>Provide technical leadership and mentorship to Quality Engineers and cross-functional teams.
</li><li>Lead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.
</li><li>Drive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.
</li><li>Lead CAPA development, implementation, effectiveness verification, and closure activities.
</li><li>Ensure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.
</li><li>Support product development activities including Design Controls, Risk Management, Verification &amp; Validation, and Design Transfer.
</li><li>Develop and maintain quality plans, inspection strategies, control plans, and quality metrics.
</li><li>Analyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.
</li><li>Lead internal and external audits, supplier audits, and regulatory inspections.
</li><li>Collaborate with Manufacturing, R&amp;D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.
</li><li>Review and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.
</li><li>Support supplier quality management activities including supplier qualification and performance monitoring.
</li><li>Drive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.
</li><li>Review engineering changes and assess quality and regulatory impacts.
</li><li>Present quality performance metrics and recommendations to senior management.
</li></ul><h3 class="jobSectionHeader">Requirements:
</h3><ul><li>Bachelor's degree in engineering, Quality, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field.
</li><li>8 15+ years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology, Aerospace, or highly regulated industries.
</li><li>Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP, and quality management systems.
</li><li>Extensive experience with CAPA, complaint handling, investigations, risk management, and process validation.
</li><li>Experience leading audits and interacting with regulatory agencies.
</li><li>Strong statistical analysis and problem-solving skills.
</li><li>Proficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.
</li><li>Excellent technical writing, communication, and leadership skills.
</li></ul><h3 class="jobSectionHeader">Preferred Qualifications:
</h3><ul><li>Master's degree in engineering or related field.
</li><li>ASQ Certifications such as:
<ul><li>Certified Quality Engineer (CQE)
</li><li>Certified Six Sigma Black Belt (CSSBB)
</li><li>Certified Manager of Quality/Organizational Excellence (CMQ/OE)
</li></ul></li><li>Experience with medical device product lifecycle management.
</li><li>Experience supporting global manufacturing operations.
</li></ul><h3 class="jobSectionHeader">Key Skills:
</h3><ul><li>Quality Systems Management.
</li><li>CAPA Leadership.
</li><li>Root Cause Analysis.
</li><li>Design Controls.
</li><li>Risk Management (ISO 14971).
</li><li>Process Validation.
</li><li>Statistical Analysis.
</li><li>Supplier Quality.</li></ul></div>

Principal Quality Engineer

Hyundai AutoEver America

<div>
 
 10607 &ndash; Software Engineer III (Data Engineer), Irvine, CA
 
 
 
 
 Company Overview
 
 
 
 Hyundai AutoEver America (HAEA) is the dynamic IT powerhouse behind Hyundai Motor Corporation, a Fortune 500 global leader in the automotive industry. As a key affiliate, we provide cutting-edge IT services and support to top brands including Kia, Genesis, Hyundai Translead, Hyundai Mobis, Hyundai Capital, and Glovis.
 
 
 HAEA offers a truly global and collaborative environment. Here, you&rsquo;ll drive innovation, boost operational efficiency, and help shape the future of mobility for the Hyundai Motor Group.
 
 
 At HAEA, we understand that IT is the cornerstone of today&rsquo;s fast-evolving digital world. By uniting all IT resources under one roof, we deliver consistent, top-quality solutions while serving as the crucial information link between Hyundai&rsquo;s Global Headquarters and North American operations.
 
 
 If you&rsquo;re passionate about technology and eager to make a real impact at a world-class company, Hyundai AutoEver America is the place to grow your career. Join us and be part of the transformation that&rsquo;s driving the future of automotive innovation.
 
 
 
 Role Overview
 
 
 
 We are seeking a motivated and detail-oriented Data Engineer to join our data engineering team. The role focuses on developing workflow automation using Apache Airflow and building scalable data pipelines. You will collaborate with data scientists, analysts, and engineering teams to ensure seamless data integration and optimize data-driven processes.
 
 
 
 What You Will Do
 
 
 
 <ul>
 <li>
 Design, build, and maintain scalable data pipelines and ETL processes to transform and integrate data from multiple sources.
 </li>
 <li>
 Develop workflow automation using Apache Airflow and manage production batches with performance tuning.
 </li>
 <li>
 Create and optimize data models, schemas, and database structures for scalability and efficiency.
 </li>
 <li>
 Implement best practices in data warehouse and MDM applications, ensuring data governance, security, and quality.
 </li>
 <li>
 Collaborate with data scientists, analysts, and business stakeholders to translate requirements into technical solutions.
 </li>
 <li>
 Develop scripts and automation tools to streamline data processing and pipeline operations.
 </li>
 <li>
 Implement automated monitoring, alerting systems, and maintain documentation for pipelines and data models.
 </li>
 <li>
 Create reports and visualizations to communicate pipeline performance and data insights.
 
 
 </li>
 </ul>
 
 Basic Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Computer Science, Information Technology, or related field.
 </li>
 <li>
 10+ years of experience in data warehouse and MDM applications.
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 Extensive knowledge of SQL and relational databases.
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 Strong programming skills in Python and PL/SQL.
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 10+ years of experience working with Informatica.
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 <li>
 Knowledge of Informatica IDMC and PowerCenter is a must.
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 Knowledge of big data technologies such as Apache Spark, Hadoop, or equivalent cloud-based services.
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 Strong understanding of data governance, security, and quality practices in cloud environments.
 
 
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 </ul>
 Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
 
 
 Salary Range - $96,500 to $138,061
 
 
 In addition to a competitive salary, this position offers a fantastic benefits package that includes comprehensive medical/dental coverage, generous PTO, education assistance, and annual merit increase eligibility in a growth-focused work environment.
 
 
 Team Culture:
 
 
 Our team thrives on collaboration, innovation, and continuous learning. We foster a supportive environment where every member is encouraged to share ideas and contribute to problem-solving. We value:
 
 
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 Passion for Technology: We are enthusiastic about emerging technologies and their potential to transform the automotive industry.
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 Agility: We work in an agile environment, adapting quickly to changes and continuously improving our processes.
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 Teamwork: We believe in the power of teamwork and collaboration, supporting each other to achieve common goals.
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 Growth: We prioritize personal and professional growth, offering opportunities for learning and development.
 </li>
 <li>
 Inclusivity: We maintain an inclusive culture where diverse perspectives are valued, and everyone feels welcome.
 
 
 </li>
 </ul>
 
 Our Company adheres to the equal employment opportunity guidelines set forth by federal, state and local laws. The information requested on this form is sought in good faith and will not be used to discriminate against the applicant based on race, religion or creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic characteristics, marital status, sex or gender (which includes pregnancy, childbirth, or related circumstances), gender identity, gender expression, age, citizenship, sexual orientation, family care or medical leave status, military and veteran status, political affiliation, or any other characteristic protected by federal, state and local laws.
 
</div>

10607 – Software Engineer III (Data Engineer)

<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

Arkham Technology Ltd.

Software EngineerMust be U.S. citizen due to U.S. Government contract requirements.Must be eligible to obtain and maintain a DoD Secret clearance. Active clearance preferred.Arkham Technology is a leader in cutting-edge engineering solutions, providing advanced technologies to support mission-critical applications. Our team is dedicated to delivering innovative and reliable solutions to meet the complex challenges of modern defense and commercial industries.Position Overview:Arkham Technology is seeking an Embedded Software Engineer with expertise in embedded systems and software development to play a crucial role in leading the development and implementation of embedded software solutions for our company's products. You will provide technical guidance and ensure the successful delivery of high-quality embedded software solutions.Key Responsibilities:&middot; Design, code, test, integrate and document firmware and software for embedded systems and communication products&middot; Support software engineering activities including interface design, system integration, code reviews, and software testing&middot; Participate in internal review of software components and systems.&middot; Create required project documentation in support of contract deliverables. Including development plans, requirement and design specifications, and test documents.&middot; Develop embedded software for network security applications, including device management software, communication protocols, device drivers, and control plane security features.&middot; Collaborate with cross-functional teams to integrate software and hardware solutions.&middot; Manage requirements, including decomposition, allocation, verification, and validationRequired Qualifications&middot; Bachelor&rsquo;s degree in Engineering, Computer Science, or a related field.&middot; 4+ years of experience in embedded systems design&middot; High proficiency in embedded C/C++ or equivalent systems language&middot; Broad spectrum of knowledge to be able to understand end-to-end network system architecture from wireless physical layer all the way up to application end-point.&middot; Understanding of MAC and Networking layer of a communication system.&middot; Deep understanding of Internet Protocol Security (IPsec), network protocols, data authentication and encryption (e.g. TLS, SSL, encryption, OpenSSL, X.509 Certificates, etc.)&middot; Knowledge and experience of different security protocols and encryption algorithms such as suite of CNSA algorithms.&middot; Experience with low-level hardware driver implementation&middot; Experience with embedded Linux&middot; Ability to work in a Bare Metal environment.&middot; Familiarity with ARM architecture.&middot; Strong problem-solving skills and ability to work in a collaborative team environment.&middot; Excellent verbal and written communication skills.&middot; U.S. Citizenship required; ability to obtain and maintain a security clearance.&middot; Willing to travel periodically, as neededDesired Qualifications&middot; Experience with systems, software and hardware development processes in DoD applications&middot; Familiarity with DoD Protocols: Knowledge of dynamic discovery processes and security protocols used in DoD networks&middot; Expertise in Cryptographic Technologies and Cross Domain Solutions&middot; Familiarity with DoD Protocols: Knowledge of dynamic discovery processes and security protocols used in DoD networks&middot; Proficiency in Cryptographic Modernization 2 Operational Management&middot; Knowledge of NETCONF/RESTCONF and YANG modeling to enhance network management and operability.&middot; Understanding of Cryptographic Key Management based on EKMS and KMI&middot; Familiarity with architecture development and system modeling tools such as Cameo Systems Modeler&middot; Knowledge of Networking and Interface technologies including Web services like RESTful and SOAP&middot; Understanding of Security requirements to provide Authentication, integrity, and confidentiality services and implementation&middot; Expertise in Public Key Infrastructure with trust chains, certificates, revocation checking, cert validation&middot; Expertise in Cryptographic mechanisms such as SHA, HMAC, Elliptic Curve, and quantum resistance approaches&middot; Understanding of Cryptographic Message Syntax (CMS)Job Type: Full-timePay: $85,000.00 - $180,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Health insurance</li><li>Life insurance</li><li>Parental leave</li><li>Referral program</li><li>Vision insurance</li></ul>Application Question(s):<ul><li>How did you hear about this opportunity? (Indeed, LinkedIn, Flyers, or other)</li><li>Have you worked with Secure Boot in any of your previous roles, particularly in the context of embedded systems or firmware security?</li><li>Are you a US citizen?</li></ul>Work Location: In person

Embedded Software Engineer

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