Irvine, California, United States · On-site
$81k–$114k/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: MicroCT Imaging, Laboratory Operations, Equipment Calibration, Validation, Inventory Management
Irvine, California, United States · On-site
$125k–$135k/yr
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: Project Management, CAPEX Execution, Commissioning, Qualification, Validation
Irvine, California, United States · On-site
$115k–$135k/yr
Our Culture DZYNE Technologies is leading the future of autonomous defense. Based in Irvine, California, we develop and manufacture advanced airborne and ground-based defense solutions deployed in over 50 countries. Back…
Skills: EHS Program Development, Cal/OSHA Compliance, Environmental Compliance, Risk Assessment, Hazardous Materials Management
Irvine, California, United States · Remote OK
$43/hr–$51/hr
About DZYNE DZYNE Technologies is leading the future of autonomous defense. Based in Irvine, California, we develop and manufacture advanced airborne and ground-based defense solutions deployed in over 50 countries. Back…
Skills: UAV Systems Operation, Avionics, Electronics, TCP/IP, Ethernet
Irvine, California, United States · On-site
$99k–$145k/yr
Eaton’s IS AER FMC division is currently seeking a Sr. Quality Engineer. This role is based at our Irvine, CA facility. The expected annual salary range for this role is $99000 - $145000 a year. This position is also eli…
Skills: Process Auditing, Root Cause Analysis, AS9100, ISO 9001, Six Sigma
Irvine, California, United States · On-site
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we con…
Skills: Catia V5/V6, Mechanical Design, Design For Manufacturing (DFM), Injection Molding, Compression Molding
Irvine, California, United States · On-site
$100k–$125k/yr
Our Culture DZYNE Technologies is leading the future of autonomous defense. Based in Irvine, California, we develop and manufacture advanced airborne and ground-based defense solutions deployed in over 50 countries. Back…
Skills: C++, Python, GNC Algorithms, Robotics Software Development, SIL/HIL Testing
Irvine, California, United States · On-site
$78k–$103k/yr
Company Description WD is building the infrastructure behind the AI-driven data economy. As AI scales, so does data. Every interaction, every model, every system generates data that must be stored, managed, and made acce…
Skills: C++, TCL, Python, Hardware Debugging, Signal Integrity
Irvine, California, United States · On-site
$118k–$197k/yr
Work Flexibility: Onsite Stryker is hiring an Associate Manager, Quality Assurance in Irvine, CA to lead a high-performing Quality Operations team and drive quality excellence across manufacturing and business functions.…
Skills: Quality Assurance, Quality Engineering, Compliance, Risk Prevention, Continuous Improvement
Irvine, California, United States · On-site
$108k–$153k/yr
Imagine how your ideas and expertise can change a patient’s life. Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standard…
Skills: Quality Engineering, Six Sigma, Lean Manufacturing, Root Cause Analysis, CAPA
Irvine, California, United States · On-site
$156k–$260k/yr
Work Flexibility: Onsite The Senior Manager, Operations will manage all manufacturing resources and operations within a regulated Value Stream and is accountable for its P&L performance. They will partner closely with an…
Skills: Operations Management, P&L Management, Lean Manufacturing, Regulatory Compliance, Quality Management Systems
Irvine, California, United States · Hybrid
$190k–$260k/yr
We are seeking an exceptional Staff Spacecraft Systems Engineer to serve as a Chief Program Engineer on an upcoming new product line program focused on GEO Space Domain Awareness missions relying on highly maneuverable a…
Skills: Spacecraft Systems Engineering, Satellite Architecture, Requirements Decomposition, Technical Baseline Management, Mission CONOPS
Irvine, California, United States · Hybrid
$167k–$209k/yr
About Us Rivian and Volkswagen Group Technologies is a joint venture between two industry leaders with a clear vision for automotive’s next chapter. From operating systems to zonal controllers to cloud and connectivity s…
Skills: Technical Program Management, Electronics Design, PCBA Design, Validation and Integration, Risk Mitigation
Irvine, California, United States · On-site
$92k–$130k/yr
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments…
Skills: Regulatory Affairs, Product Submissions, Compliance, Medical Device Regulations, Technical Documentation
Irvine, California, United States · On-site
$26/hr–$30/hr
"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold t…
Skills: Microbiological Testing, Environmental Monitoring, Aseptic Practices, cGMP, Good Documentation Practices
Irvine, California, United States · Hybrid
$140k–$185k/yr
Employment Type: Salaried Work Arrangement: Hybrid Position Summary: The Principal IT QA engineer will be a hands-on, individual contributor responsible for designing and developing our testing automation framework utili…
Skills: Python, Java, Playwright, PyTest, TestNG
Irvine, California, United States · On-site
$180k–$220k/yr
What We Do Forma is a next-generation Contract Development and Manufacturing Organization (CDMO) based in Irvine, California. The company was recently formed through the acquisition of the Irvine operations from BioDuro …
Skills: GMP Regulations, Solid Oral Dosage, Resource Planning, Budget Management, Project Management
Irvine, California, United States · On-site
$146k–$194k/yr
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century…
Skills: Mechanical Design, Engineering Management, 3D CAD, GD&T, Design for Manufacturability
Irvine, California, United States · On-site
$191k–$253k/yr
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century…
Skills: Mechanical Design, Engineering Management, 3D CAD, GD&T, Design for Manufacturability
Irvine, California, United States · On-site
$34/hr–$38/hr
PRIMARY DUTIES AND RESPONSIBILITIES: Perform and/or assist with analytical testing of raw materials, in-process samples, and finished products.Utilize analytical laboratory instrumentation with supervision.Comply with cG…
Skills: Analytical Testing, cGMP Regulations, Method Validation, Method Troubleshooting, HPLC
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The role focuses on performing microCT scanning and imaging to support R&D while coordinating day-to-day laboratory operations. It involves ensuring compliance with quality and safety standards and developing complex validation protocols.
Requires an Associate's degree with 13+ years of experience or 15+ years of experience in a medical device or laboratory setting. Preferred qualifications include expertise in electrical, mechanical, and pneumatic systems, as well as knowledge of FDA and ISO regulations.
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.
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 portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The TMTT Laboratory Staff Technologist plays a key role in maintaining and advancing laboratory capabilities by supporting microCT imaging, coordinating day-to-day lab operations, and collaborating with cross-functional teams. This position focuses on ensuring high-quality data, operational efficiency, and compliance while contributing to continuous improvement and laboratory development initiatives.
Perform microCT scanning and imaging to support R&D and cross-functional project teams, delivering timely and high-quality data acquisition and analysis (40%)
Coordinate laboratory activities in assigned areas, including testing, equipment calibration, validation, maintenance, and inventory/procurement management (30%)
Partner with stakeholders to ensure compliance with quality, safety, and environmental requirements; support root cause investigations, implement corrective actions, participate in internal and external audits (10%)
Develop and execute complex protocols (IQs, validations) in collaboration with cross-functional teams to support laboratory and project needs (10%)
Analyze performance and quality metrics; recommend and implement operational improvements (5%)
Provide technical expertise for corporate initiatives related to laboratory utilization, design (e.g., workflow, airflow, electrical) and construction (5%)
Other incidental duties: General work area housekeeping, cross-functional team meetings, maintaining certification in required areas of operation
What you’ll need (Required):
Associate's Degree or equivalent and 13+ years of previous experience in medical device or a laboratory setting OR
15+ years of previous experience in medical device or a laboratory setting
What else we look for (Preferred):
Electrical experience is highly preferred
Mechanical/pneumatic experience is highly preferred
Electronic and Controls is highly preferred
Excellent written and verbal communication, interpersonal, and relationship building skills
Excellent computer skills, including usage of MS Office and Maximo
Moderate to proficient use of micro CTs
Knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
Ability to write technical documents
Must be able to work independently, collaborate, and provide guidance and training to lower-level technicians
Able to work well in a dynamic, fast-paced environment
Provide feedback in a professional, direct, and tactful manner
Represent the organization to outside contacts, e.g., contractors and vendors
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment
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 $81,000 - $114,000 (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.
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
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