Fiscal Year

2022

Case Number

A-21124-81567

Case Status

Certified-Expired

Received Date

2021-05-26

Decision Date

2021-10-25

Refile

N

Original File Date

2022-01-01 10:19:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AMGEN INC.

Employer Name Slug

amgen-inc

Employer Address 1

ONE AMGEN CENTER DRIVE

Employer Address 2

Employer City

THOUSAND OAKS

Employer City Slug

thousand-oaks

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

91320

Employer Phone

805-447-1000

Employer Number of Employees

12973

Employer Year Commenced Business

1980

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Jenny Cummings

Employer Contact Address 1

2202 N. Westshore Blvd.

Employer Contact Address 2

Employer Contact City

Tampa

Employer Contact State/Province

FLORIDA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

33607

Employer Contact Phone

813-392-0428

Employer Contact Email

jen01@amgen.com

Agent Attorney Name

Laura Bloniarz

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

9728617144

Agent Attorney Address 1

2400 N. Glenville Dr., Building A

Agent Attorney Address 2

Suite 100

Agent Attorney City

Richardson

Agent Attorney State/Province

TEXAS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

75082

Agent Attorney Email

labloniarz@balglobal.com

PW Track Number

P10020268844900

PW SOC Code

17-2031

PW SOC Title

Biomedical Engineers

PW Skill Level

Level III

PW Wage

104624.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-02-26

PW Expiration Date

2021-06-30

Wage Offer From

123768.75

Wage Offer To

0.00

Average Salary

123768.75

Wage Unit of Pay

Year

Worksite Address 1

One Amgen Center Drive

Worksite Address 2

Worksite City

Thousand Oaks

Worksite City Slug

thousand-oaks

Worksite State

CALIFORNIA

Worksite Postal Code

91320

Job Title

Senior Engineer

Job Title Slug

senior-engineer

Minimum Education

Master's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

36

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

MASTERS DEGREE IN MECHANICAL, ELECTRICAL, BIOMEDICAL OR, BIO ENGINEERING OR RELATED FIELD AND 3 YEARS OF EXPERIENCE IN LEADING AND EXECUTING TIMELY AND THOROUGH TECHNICAL INVESTIGATIONS FOR COMPLEX MEDICAL DEVICE HARDWARE AND SOFTWARE COMPLAINTS ASSOCIATED WITH PRODUCT DESIGN AND USABILITY, PER FDA 21 CFR 820 ISO 13485 GMP UTILIZING ONE OR MORE DIVERSE EXPERIMENTAL ANALYTICAL TOOLS, INCLUDING CT, MRI, XRAY TO COLLECT AND ANALYZE PRODUCT COMPLAINT FAILURE DATA; AUTHORING HIGH QUALITY AND COMPLEX TECHNICAL REPORTS AND PROTOCOLS; PROVIDING TECHNICAL LEADERSHIP TO IDENTIFY THE FAILURE MODES FOR MEDICAL DEVICE HARDWARE AND SOFTWARE COMPLAINTS USING TOOLS AND PROCESSES SUCH AS FISHBONE DIAGRAMS, 5 WHYS, AND RISK ASSESSMENTS FMEAS OR FAULT TREE ANALYSIS; DEVELOPING CROSS FUNCTIONAL SOLUTIONS TO REDUCE COMPLAINTS BASED ON OUTPUT OF ROOT CAUSE ANALYSIS BY APPLYING MEDICAL DEVICE FDA AND ISO GMP INCLUDING DESIGN CONTROLS, PRODUCTION AND PROCESS CONTROLS, CAPA, MANAGEMENT CONTROLS; AND DOCUMENTING AND IDENTIFYING WAYS TO CORRECT AND PREVENT COMPLAINT ROOT CAUSES CAPA USING ONE OR MORE GENERALLY USED QUALITY MANAGEMENT SOFTWARE INCLUDING SALESFORCE, TRACKWISE, AND MASTERCONTROL.br ORbr BACHELORS DEGREE IN MECHANICAL, ELECTRICAL, BIOMEDICAL, OR BIO ENGINEERING OR RELATED FIELD AND 5 YEARS OF PROGRESSIVE EXPERIENCE IN LEADING AND EXECUTING TIMELY AND THOROUGH TECHNICAL INVESTIGATIONS FOR COMPLEX MEDICAL DEVICE HARDWARE AND SOFTWARE COMPLAINTS ASSOCIATED WITH PRODUCT DESIGN AND USABILITY, PER FDA 21 CFR 820 ISO 13485 GMP UTILIZING ONE OR MORE DIVERSE EXPERIMENTAL ANALYTICAL TOOLS, INCLUDING CT, MRI, XRAY TO COLLECT AND ANALYZE PRODUCT COMPLAINT FAILURE DATA; AUTHORING HIGH QUALITY AND COMPLEX TECHNICAL REPORTS AND PROTOCOLS; PROVIDING TECHNICAL LEADERSHIP TO IDENTIFY THE FAILURE MODES FOR MEDICAL DEVICE HARDWARE AND SOFTWARE COMPLAINTS USING TOOLS AND PROCESSES SUCH AS FISHBONE DIAGRAMS, 5 WHYS, AND RISK ASSESSMENTS FMEAS OR FAULT TREE ANALYSIS; DEVELOPING CROSS FUNCTIONAL SOLUTIONS TO REDUCE COMPLAINTS BASED ON OUTPUT OF ROOT CAUSE ANALYSIS BY APPLYING MEDICAL DEVICE FDA AND ISO GMP INCLUDING DESIGN CONTROLS, PRODUCTION AND PROCESS CONTROLS, CAPA, MANAGEMENT CONTROLS; AND DOCUMENTING AND IDENTIFYING WAYS TO CORRECT AND PREVENT COMPLAINT ROOT CAUSES CAPA USING ONE OR MORE GENERALLY USED QUALITY MANAGEMENT SOFTWARE INCLUDING SALESFORCE, TRACKWISE, AND MASTERCONTROL.br br Any suitable combination of experience of education, training, or experience is acceptable.

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

2021-03-18

SWA Job Order End Date

2021-04-20

Sunday Edition Newspaper

Y

First Newspaper Name

Los Angeles Daily News

First Advertisement Start Date

2021-04-04

Second Newspaper Ad Name

Los Angeles Daily News

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-04-11

Employer Website From Date

2022-01-01 10:19:19

Employer Website To Date

2022-01-01 10:19:19

Professional Organization Ad From Date

2021-03-29

Professional Organization Advertisement To Date

2021-04-05

Job Search Website From Date

2021-03-29

Job Search Website To Date

2021-04-05

Employee Referral Program From Date

2022-01-01 10:19:19

Employee Referral Program To Date

2022-01-01 10:19:19

Local Ethnic Paper From Date

2021-04-07

Local Ethnic Paper To Date

2021-04-07

Radio/TV Ad From Date

2022-01-01 10:19:19

Radio/TV Ad To Date

2022-01-01 10:19:19

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOENGINEERING

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

UNIVERSITY OF ILLINOIS AT CHICAGO

Foreign Worker Education Institution Address 1

1200 W HARRISON STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CHICAGO

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

60607

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Laura Bloniarz

Preparer Title

Senior Associte

Preparer Email

labloniarz@balglobal.com

Employer Information Declaration Name

Jen Cummings

Employer Information Declaration Title

HR Representative