Irvine, California, United States · On-site
$108k–$153k/yr
Please note that this is an onsite role, and the successful candidate will be expected to work from our corporate Irvine, CA campus. Imagine how your ideas and expertise can change a patient’s life. Our Quality teams hel…
Skills: Process Validation, Test Method Development, Supplier Quality Engineering, Gage Studies, Process Capability Studies
Irvine, California, United States · On-site
$125k–$206k/yr
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination …
Skills: Machine Learning, Signal Processing, Deep Reinforcement Learning, Python, MATLAB
Irvine, California, United States · On-site
$76k–$102k/yr
POSITION PROFILE Position Title: Mechanical Engineer I Reports To: Mechanical Engineer Manager Key Cultural Competencies: Highly ethical, honest, operates from the highest levels of integrity Passionate for his/her work,…
Skills: SolidWorks, Mechanical Design, Systems Integration, Thermal Analysis, Structural Analysis
Irvine, California, United States · On-site
$103k–$171k/yr
Work Flexibility: Onsite Stryker is seeking a Staff Engineer to join our Peripheral Vascular (PV) team. In this role, you will serve as a Technical Lead, driving engineering initiatives across both manufacturing and rese…
Skills: Manufacturing Process Design, Qualification Verification and Validation, Six Sigma, Risk Analysis, FMEA
Irvine, California, United States · Hybrid
$82k–$113k/yr
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day,…
Skills: Product Development, CAD Software, SolidWorks, Design for Manufacturability, Verification and Validation
Irvine, California, United States · Hybrid
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Skills: Nutrition Counseling, Medical Nutrition Therapy, Motivational Interviewing, Behavior Change Counseling, Eating Disorder Treatment
Irvine, California, United States · Remote OK
$123k–$130k/yr
FirstCarbon Solutions (FCS), an ADEC Innovation, is seeking a Senior Sustainability Project Manager, Lead GHG Verifier. This role will lead the development and independent 3rd-party verification of GHG inventories (Scope…
Skills: Greenhouse Gas Accounting, Life Cycle Assessment, Environmental Metrics Accounting, Sustainability Reporting, Project Management
Irvine, California, United States · On-site
$120k–$145k/yr
Do Epic Science TAE is the world’s first private fusion energy company, founded in 1998 to commercialize the cleanest, safest, most affordable, and sustainable form of carbon-free power. We are applying science and…
Skills: Plasma Control, FPGA Development, Embedded C/C++, Matlab, Simulink
Irvine, California, United States · On-site
$33/hr–$39/hr
Job Summary: The Test Engineering Technician supports the execution of verification, validation, reliability, and performance testing for Masimo products and technologies. This role is responsible for setting up and cond…
Skills: Verification Testing, Validation Testing, Reliability Testing, Electronic Troubleshooting, Wiring
Irvine, California, United States · On-site
$142k–$269k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Clinical Pharmacology, PK/PD Modeling, Pharmacometrics, Regulatory Strategy, Phase 1-4 Study Design
Irvine, California, United States · On-site
$182k–$346k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Regulatory Affairs, Drug Development, CMC Experience, Global CMC Regulatory Requirements, Influencing Skills
Irvine, California, United States · On-site
$73k–$96k/yr
ERM is hiring an Archaeological Field Technician to support future needs of survey efforts for projects located in throughout California and neighboring states. Archaeological Field Technicians will assist with or conduc…
Skills: Archaeological Field Survey, Construction Monitoring, Cultural Resource Management, Subsurface Excavation, Shovel Testing
Irvine, California, United States · On-site
$103k–$171k/yr
Work Flexibility: Onsite What You Will Do Lead the design, development, and optimization of mechanical medical device components, assemblies, and/or subsystems from concept through commercialization. Translate user, cust…
Skills: Mechanical Design, Medical Device Development, SolidWorks, GD&T, Design for Manufacturability
Irvine, California, United States · On-site
$120k–$145k/yr
A Day in Your Life at MKS: As a Product Line Manager, you will partner with engineering, sales, operations, and customers to drive early-stage customer engagement, evaluate new business opportunities, and translate techn…
Skills: Technical Marketing, Business Development, Product Management, Applications Engineering, Voice Of Customer
Irvine, California, United States · On-site
$59k–$83k/yr
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As …
Skills: Clinical Trial Management, Device Accountability, Data Analysis, Regulatory Reporting, Process Improvement
Irvine, California, United States · On-site
$140k–$170k/yr
We’re expanding our satellite manufacturing capability and seeking a Senior Industrial Engineer to lead factory optimization initiatives and drive scalable, efficient spacecraft production. This role blends advanced indu…
Skills: Value Stream Mapping, Discrete-Event Simulation, Throughput Modeling, Capacity Modeling, Workstation Layout Design
Irvine, California, United States · On-site
$109k–$166k/yr
Virgin Galactic is seeking a talented and motivated technical engineer to join our Materials & Process team to help get our next generation of spaceships to space! Guided by our values, “Safety above All”, we proactively…
Skills: Materials Testing, Composite Materials, Mechanical Testing, Statistical Analysis, CAD Modelling
Irvine, California, United States · On-site
$24/hr–$30/hr
Job DetailsJob Location: Irvine C2 - Irvine, CA 92604Position Type: Part TimeEducation Level: Completed Bachelor's Degree or higherSalary Range: $24.00 - $30.00 HourlyTravel Percentage: NegligibleJob Category: EducationA…
Skills: Biology Tutoring, Chemistry Tutoring, Lesson Planning, Classroom Management, Educational Technology
Irvine, California, United States · On-site
$28/hr–$35/hr
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration s…
Skills: Microbiology, GLP, GMP, Environmental Monitoring, Data Collection
Irvine, California, United States · Hybrid
$150k–$213k/yr
Overview At Turion Space, we live at the intersection of the tech, aerospace, and defense industries. Our company thrives on solving hard problems and delivering software that our customers can rely upon. Our clients ran…
Skills: C++, Python, CMake, MATLAB, Fortran
Irvine, California, United States • On-site
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Lead parts qualification efforts with external suppliers and develop validated test methods for critical component features. Manage supplier-related non-conformances, conduct audits, and collaborate cross-functionally to ensure product safety and integrity.
Requires a Bachelor's degree in Engineering or Science with 4+ years of experience, or a Master's degree with 3+ years of experience in quality or manufacturing engineering. Experience in highly regulated industries and the ability to travel up to 25% are mandatory.
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
The Senior Supplier Quality Engineer will play a key role on critical projects within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. The Sr. Supplier Quality Engineer will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.
How You Will Make an Impact:
Lead/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.
Manage component and supplier qualification activities from initiation to closure.
Support component specification development, identification of critical features, development of inspection methods and plans.
Support risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities.
Conduct on-site supplier audits.
Manage supplier-related non-conformances.
Manage supplier corrective action requests (SCAR) from initiation to closure.
Report on supplier part qualification status at recurring cross-functional project meetings.
Collect and analyze Quality metrics relating to Supplier Quality.
Communicate supplier quality risks to upper management during Management Review and project meetings and identify solutions to mitigate risks.
Support process and system improvement projects as assigned by manager.
Bachelor’s degree in Engineering or Scientific field with at least four (4) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities; OR Master’s degree with three (3) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities.
Highly regulated industry experience.
Must have ability to travel up to 25%.
Engineering degree.
Medical Device, Aerospace, or Automotive industry experience.
Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
Experience and/or proficient knowledge of Design Controls and test method development/validations.
Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
Knowledge of GD&T and ability to read and interpret drawings.
Good understanding of process validations (IQ, OQ, PQ)
Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
Good interpersonal skills, with the ability to negotiate and influence change.
Possess the ability to multi-task, while maintaining high attention to detail.
Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers).
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(highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
There are currently 483 open science & research positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Edwards Lifesciences, UCI Health, Allergan, Tarsus Pharmaceuticals, Inc., FieldAI, among others. Browse the listings above to see every active employer.
Yes — 102 of the 483 open science & research positions offer remote or hybrid work (28 remote, 74 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
