Fiscal Year

2023

Case Number

A-22010-96027

Case Status

Certified

Received Date

2022-03-18

Decision Date

2022-11-22

Refile

N

Original File Date

2023-01-01 18:09:06

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDWARDS LIFESCIENCES LLC

Employer Name Slug

edwards-lifesciences-llc

Employer Address 1

ONE EDWARDS WAY

Employer Address 2

Employer City

IRVINE

Employer City Slug

irvine

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92614

Employer Phone

(949) 250-6338

Employer Number of Employees

15000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Tracie Pham

Employer Contact Address 1

One Edwards Way

Employer Contact Address 2

Employer Contact City

Irvine

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92614

Employer Contact Phone

(949) 250-3444

Employer Contact Email

Tracie_Pham@edwards.com

Agent Attorney Name

Diana V Coker

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

Diana@larrabee.com

PW Track Number

P10021212494797

PW SOC Code

17-2199

PW SOC Title

Manufacturing Engineers OES 172199.04

PW Skill Level

Level II

PW Wage

91166.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-03-08

PW Expiration Date

2022-06-30

Wage Offer From

91166.00

Wage Offer To

0.00

Average Salary

91166.00

Wage Unit of Pay

Year

Worksite Address 1

One Edwards Way

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92614

Job Title

Manufacturing Engineer, Operations Integrator

Job Title Slug

manufacturing-engineer-operations-integrator

Minimum Education

Master's

Major Field of Study

Engineering (Chemical, Mechanical, Biomedical) or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.4B

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

2

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

12

Accept Alternative Job Title

design transfer, manufacturing engineering or a combination of these fields see H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.8A through C In lieu of a Masters degree and 1 year of experience, employer will accept a Bachelors degree or equivalent in Engineering Chemical, Mechanical, Biomedical or a related field and 2 years of experience in design transfer, manufacturing engineering or a combination of these fields. Experience must be in the medical device industry.br br Contd from H.10B Experience must be in the medical device industry.br br H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Medical design transfer and operations integration. 2. Working with laboratory and industrial equipment, including tensile testing machines, compression and fatigue testing machines, leak and flow testers, and ultrasonic welders; utilizing automation equipment including feeder bowls, vision and cam driver systems, servos, and high speed conveyors. 3. Reading and interpreting engineering drawings to identify the required features and application; this must include applying mechanical and chemical principles tensile modules, plastic deformation, and adhesion capabilities towards material and manufacturing process selection based on features and application. 4. Working with equipment and processes for PCBA Printed Circuit Board Assembly, SMT Surface Mount Technology, injection molding, cable manufacturing, high volume at least 10 million units per year product assembly, and environmental controls Class 8 or higher ISO clean rooms and water processing. 5. Utilizing the following process development tools and technologies range finding and correlation studies to identify process inputs and outputs. 6. Utilizing process validation principles, including Installation Qualification, Operational Qualification and Process Qualification. 7. Working with ISO 13485 and Title 21 CFR FDA regulatory submissions for USA, European Union countries and China. 8. Utilizing CAD and SolidWorks to generate drawings and 3D models for mechanical designs of parts and fixtures. 9. Optimizing manufacturing processes using Six Sigma and Lean engineering methods. 10. Conducting continuous process improvement and redesign or design of equipment and tools. 11. Developing experiments and tests including writing and executing protocols to qualify and validate manufacturing processes and test methods, analyzing test results and providing recommendations for changes or improvements. 12. Analyzing and resolving manufacturing and compliance issues, including CAPA, nonconformance, and audit observations. 13. Developing manufacturing processes for high volume at least 10 million units per year automated manufacturing. 14. Developing manufacturing specifications for automated manufacturing processes. 15. Working directly with suppliers to transfer design specification and to develop Design for Manufacturability DFM plans. 16. Establishing project plans using Project Plan and Risk Analysis project management tools, including Microsoft Project. 17. Developing and executing automation and operations strategy for endtoend supply chain manufacturing for high volume at least 10 million units per year products. 18. Developing, maintaining and closing commercial rampup strategy and plan. Academic background, training or work experience to include 19. Statistical techniques, including regression, sample size determination, hypothesis testing, Design of Experiments DOE, capability analysis, Gage RR, SPC Statistical Process Control, and ANOVA Analysis of Variance.br br Hiring requirements Drug TestingScreening, Background Checks.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2021-11-01

SWA Job Order End Date

2021-12-01

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2021-11-14

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-11-21

Employer Website From Date

2023-01-01 18:09:06

Employer Website To Date

2023-01-01 18:09:06

Professional Organization Ad From Date

2023-01-01 18:09:06

Professional Organization Advertisement To Date

2023-01-01 18:09:06

Job Search Website From Date

2021-11-15

Job Search Website To Date

2021-11-21

Employee Referral Program From Date

2023-01-01 18:09:06

Employee Referral Program To Date

2023-01-01 18:09:06

Local Ethnic Paper From Date

2021-11-15

Local Ethnic Paper To Date

2021-11-15

Radio/TV Ad From Date

2023-01-01 18:09:06

Radio/TV Ad To Date

2023-01-01 18:09:06

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

NIGERIA

Foreign Worker Birth Country

NIGERIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

CHEMICAL ENGINEERING

Foreign Worker Years of Education Completed

2018

Foreign Worker Institution of Education

COLUMBIA UNIVERSITY

Foreign Worker Education Institution Address 1

116TH STREET BROADWAY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

NEW YORK

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

10027

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Diana V Coker

Preparer Title

PartnerAttorney at Law

Preparer Email

diana@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility