Fiscal Year

2024

Case Number

A-23006-83836

Case Status

Certified

Received Date

2023-02-07

Decision Date

2024-03-08

Refile

N

Original File Date

2024-01-01 00:53:34

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

16000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Caitlin Kelly

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) 250-6338

Employer Contact Email

Caitlin_Kelly@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

P10022143198651

PW SOC Code

11-3071.04

PW SOC Title

Supply Chain Managers

PW Skill Level

Level IV

PW Wage

129854.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-09

PW Expiration Date

2023-06-30

Wage Offer From

160000.00

Wage Offer To

0.00

Average Salary

160000.00

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

Sr. New Product Introduction Manager, Supply Chain

Job Title Slug

sr-new-product-introduction-manager-supply-chain

Minimum Education

Bachelor's

Major Field of Study

Industrial Engineering & Management, Supply Chain Management 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

Master's

Accept Alternative Combination Education Years

7

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

108

Accept Alternative Job Title

progressive experience in supply chain management contd in H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.8 In lieu of a Bachelors degree and 9 years of experience, employer will accept a Masters degree or equivalent in Industrial Engineering and Management, Supply Chain Management, or a related field and 7 years of experience in supply chain management, operations, procurement, logistics or a combination of these fields; experience must be in the medical industry regulated by FDA, Dekra or TUV.br br Contd from H.10B operations, procurement, logistics or a combination of these fields; experience must be in the medical industry regulated by FDA, Dekra or TUV.br br Contd from 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. Five years of experience in New Product introduction in the medical device industry from concept to commercialization. 2. Five years of experience in Value Analysis managing cost reductions initiatives to meet strategic plans. 3. Three years of experience working with Class I, Class II or Class III structural heart or critical care medical devices. 4. Two years of experience in logistics management, including procurement, inventory planning, forecasting and demand analysis. 5. Supply chain experience managing minimum 5 supplier strategies, and development of procurement operations both domestic and international. 6. Supporting internal and external audits by international and domestic regulatory agencies including FDA and TUV. 7. Managing validations and scale up initiatives of product launch projects. 8. Leading and partnering with crossfunctional teams Planning, Sourcing, Distribution, Logistics, Engineering, Pilot and Commercial Manufacturing, on the integration of New Products into manufacturing; must include lifecycle management planning, sustaining activities and Operations. 9. Working with medical device regulatory authorities, notified bodies and industry standards, including FDA, TUV, Reach, or ROHAS. 10. Driving alignment of supply chain functions within the operations network including external suppliers. 11. Reading technical prints and drawings including GDT Geometric Dimensioning and Tolerancing. 12. Preparing for and presenting technical documentation to executive leadership; must include Operations Integration Plans, Manufacturing Readiness Reviews Key Metrics for cost, capacity planning, transfer plans plus development and managing of dashboards. 13. Project management leadership experience, including developing and managing project budgets, and supporting business case development including considerations of net present value and internal rate of return on capital investments. 14. Experience with manufacturing engineering, design for manufacturability, design and process excellence methodologies, cGMP, EHS guidelines, supplier development, and process validation. 15. Working with design controls for Class II and Class III medical devices, including at least one of the following device sterilization, implantable using NiTi Nitinol, CoCr Cobalt Chromium, Stainless Steel SS Textiles or tissue, electromechanical devices or catheterbased delivery systems. 16. Working with Critical to Quality CTQ design elements and cascading CTQs to design inputs and outputs and establishing process controls and limits. 17. Working with JD Edwards or SAP Enterprise Resource Planning ERP systems. 18. Planning and supporting all Operations activities related to Planning, Sourcing, Manufacturing and Distribution. Any and all experience can be gained concurrently.br Hiring requirements Drug TestingScreening, 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

2022-09-26

SWA Job Order End Date

2022-10-27

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2022-10-09

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-10-16

Employer Website From Date

2024-01-01 00:53:34

Employer Website To Date

2024-01-01 00:53:34

Professional Organization Ad From Date

2024-01-01 00:53:34

Professional Organization Advertisement To Date

2024-01-01 00:53:34

Job Search Website From Date

2022-10-10

Job Search Website To Date

2022-10-16

Employee Referral Program From Date

2024-01-01 00:53:34

Employee Referral Program To Date

2024-01-01 00:53:34

Local Ethnic Paper From Date

2022-10-10

Local Ethnic Paper To Date

2022-10-10

Radio/TV Ad From Date

2024-01-01 00:53:34

Radio/TV Ad To Date

2024-01-01 00:53:34

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

INDUSTRIAL ENGINEERING AND MANAGEMENT

Foreign Worker Years of Education Completed

2010

Foreign Worker Institution of Education

SHENKAR COLLEGE OF ENGINEERING AND DESIGN

Foreign Worker Education Institution Address 1

ANNA FRANK 12

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

RAMAT GAN

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

ISRAEL

Foreign Worker Education Institution Postal Code

5252626

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

Partner Attorney at Law

Preparer Email

Diana@larrabee.com

Employer Information Declaration Name

Tracie M Pham

Employer Information Declaration Title

Senior Talent Mobility Specialist