Fiscal Year

2021

Case Number

A-20217-84770

Case Status

Certified

Received Date

2020-10-01

Decision Date

2021-05-19

Refile

N

Original File Date

2021-01-01 09:24:51

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) 250-3444

Employer Number of Employees

14000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Nickie Engle

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) 250-2947

Employer Contact Email

Nickie_Engle@edwards.com

Agent Attorney Name

Claudia P Martorell

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

cmartorell@larrabee.com

PW Track Number

P10020045323206

PW SOC Code

17-2112

PW SOC Title

Industrial Engineers

PW Skill Level

Level II

PW Wage

89731.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-05-05

PW Expiration Date

2020-08-03

Wage Offer From

89731.00

Wage Offer To

0.00

Average Salary

89731.00

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

Quality Engineer

Job Title Slug

quality-engineer

Minimum Education

Bachelor's

Major Field of Study

Engineering (Mechanical or Biomedical) or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

engineering experience in a regulatory environment contd in H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Contd from H.10B Employer will accept pre and postBachelors degree experience.br br Work experience to include 1. Conducting medical equipment qualifications, process validations, and test method validations. 2. Utilizing Gage RR statistical techniques. 3. Working with lab or industrial equipment to include at least four of the following Tensile testers Instron, Force and Toque gauges, Pin gauges, simulated use equipment glass models and water tanks, Leak testers, burst testers, calipers, micrometers, Optical measurement equipment Keyence. 4. Conducting tensile, torque, and simulated use insertion and retrieval testing of Transcatheter Delivery System. 5. Utilizing CAD to develop test fixtures and mistake proof solutions. 6. Preparing and presenting project proposals and status updates to both internal and customer executives. 7. Presenting findings, recommendations and solutions to crossfunctional peers and senior management to gain their approval. 8. Working as a part of a crossfunctional team. 9. Developing and executing variable and attribute Test Methods Validations TMV. 10. Project management for the planning and rollout of new or modified quality management system process. 11. Working with regulations and standards related to quality management systems for the design, development, manufacturing and distribution of medical devices including ISO 13485, and ISO 14971. 12. Writing and developing Standard Operating Procedures SOP used for inspection. 13. Inspection equipment purchase, induction, calibration, maintenance planned and unplanned and storage, including investigation of out of tolerance conditions. 14. Problem solving using Six Sigma, DMAIIC or any other datadriven methodology. 15. Analyzing and resolving manufacturing and compliance issues, including CAPA, nonconformances, and audit observations. 16. Executing product line experiments and tests including writing and executing protocols to qualify and validate manufacturing processes. Position requires 2.5 domestic and 2.5 international travel; expenses paid by employer.br Hiring Requirements Drug TestingScreening, Background Checks, Motor Vehicle Background Check.

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

2020-05-11

SWA Job Order End Date

2020-06-11

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2020-06-07

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-06-14

Employer Website From Date

2021-01-01 09:24:51

Employer Website To Date

2021-01-01 09:24:51

Professional Organization Ad From Date

2021-01-01 09:24:51

Professional Organization Advertisement To Date

2021-01-01 09:24:51

Job Search Website From Date

2020-06-15

Job Search Website To Date

2020-06-19

Employee Referral Program From Date

2021-01-01 09:24:51

Employee Referral Program To Date

2021-01-01 09:24:51

Local Ethnic Paper From Date

2020-06-15

Local Ethnic Paper To Date

2020-06-15

Radio/TV Ad From Date

2021-01-01 09:24:51

Radio/TV Ad To Date

2021-01-01 09:24:51

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

ISRAEL

Foreign Worker Birth Country

ISRAEL

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

MECHANICAL ENGINEERING

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

TELAVIV ACADEMIC COLLEGE OF ENGINEERING AFEKA

Foreign Worker Education Institution Address 1

BNEI EFRAIM

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

TEL AVIV

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

ISRAEL

Foreign Worker Education Institution Postal Code

6998812

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Claudia P Martorell

Preparer Title

PartnerAttorney at Law

Preparer Email

Claudia@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility