Fiscal Year

2020

Case Number

A-19233-47567

Case Status

Certified-Expired

Received Date

2019-09-09

Decision Date

2019-12-16

Refile

N

Original File Date

2020-01-01 07:52:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

SIEMENS MEDICAL SOLUTIONS USA, INC.

Employer Name Slug

siemens-medical-solutions-usa-inc

Employer Address 1

40 LIBERTY BOULEVARD

Employer Address 2

Employer City

MALVERN

Employer City Slug

malvern

Employer State

PENNSYLVANIA

Employer State Slug

pennsylvania

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19355

Employer Phone

4072574326

Employer Number of Employees

49000

Employer Year Commenced Business

1970

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Dina Castillo Ward

Employer Contact Address 1

40 Liberty Boulevard

Employer Contact Address 2

Employer Contact City

Malvern

Employer Contact State/Province

PENNSYLVANIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

19355

Employer Contact Phone

4072574326

Employer Contact Email

dina.castillo_ward@siemens.com

Agent Attorney Name

Timothy M Nelson

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy LLP

Agent Attorney Phone

73286250005175

Agent Attorney Address 1

90 Matawan Road

Agent Attorney Address 2

4th Floor

Agent Attorney City

Matawan

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7747

Agent Attorney Email

tnelson@fragomen.com

PW Track Number

P10018267409016

PW SOC Code

13-1041

PW SOC Title

Regulatory Affairs Specialists

PW Skill Level

Level IV

PW Wage

114067.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-02-01

PW Expiration Date

2019-06-30

Wage Offer From

132784.00

Wage Offer To

0.00

Average Salary

132784.00

Wage Unit of Pay

Year

Worksite Address 1

22010 South East 51st Street

Worksite Address 2

Worksite City

Issaquah

Worksite City Slug

issaquah

Worksite State

WASHINGTON

Worksite Postal Code

98029

Job Title

Regulatory Technical Specialist

Job Title Slug

regulatory-technical-specialist

Minimum Education

Bachelor's

Major Field of Study

Biomedical Engineering or related field

Required Training

N

Required Experience

Y

Required Experience Months

96

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

96

Accept Alternative Job Title

8 years of experience in the job offered or in an acceptable alternate occupation.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have 5 years of experience with the following skills experience in China medical device laws, regulations and device testing; experience with interfacing with China authorities, medical device reviewers, test labs incountry and onsite test planning, collaboration, execution, preparation of China product Clinical Evaluation Reports, Cyber Security documents, Software Description Document; experience in Japan medical device laws and regulations; experience in Japan QMS; experience in Korea medical device laws, regulations and device testing; experience in Korea GMP and manufacturing facility registration. Must have 3 years of experience with the following skills experience in Taiwan medical device laws and regulations; and experience in Taiwan manufacturing facility registration. Must have 2 years of experience with the following skills experience in BrazilMexico medical device laws and regulations; advanced technical knowledge of ultrasound medical device; 510k submission experience and advanced competency of USA FDA laws, regulations and requirements; European regulations experience including Medical Device Directive for class IIa and class III product; International standards experience including IEC 606011, 60601237, 62359, UD2, UD3, ISO 10993 and ISO 11607; and experience with relevant procedures, practices, packaging, sterilization, biocompatibility and associated medical terminology. Approximately 20 travel required.

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

2019-03-27

SWA Job Order End Date

2019-04-28

Sunday Edition Newspaper

Y

First Newspaper Name

Seattle Times

First Advertisement Start Date

2019-04-21

Second Newspaper Ad Name

Seattle Times

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-04-28

Employer Website From Date

2020-01-01 07:52:19

Employer Website To Date

2020-01-01 07:52:19

Professional Organization Ad From Date

2020-01-01 07:52:19

Professional Organization Advertisement To Date

2020-01-01 07:52:19

Job Search Website From Date

2019-04-22

Job Search Website To Date

2019-05-06

Employee Referral Program From Date

2019-07-15

Employee Referral Program To Date

2019-07-29

Local Ethnic Paper From Date

2019-04-26

Local Ethnic Paper To Date

2019-04-26

Radio/TV Ad From Date

2020-01-01 07:52:19

Radio/TV Ad To Date

2020-01-01 07:52:19

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

SOUTH KOREA

Foreign Worker Birth Country

SOUTH KOREA

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2004

Foreign Worker Institution of Education

YONSEI UNIVERSITY

Foreign Worker Education Institution Address 1

YONSEI UNIVERSITY

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

WONJU

Foreign Worker Education Institution State/Province

GANGWONDO

Foreign Worker Education Institution Country

SOUTH KOREA

Foreign Worker Education Institution Postal Code

26498

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Timothy M Nelson

Preparer Title

Partner

Preparer Email

tnelson@fragomen.com

Employer Information Declaration Name

Maria Davydova

Employer Information Declaration Title

Immigration Consultant