Fiscal Year

2024

Case Number

A-22343-70948

Case Status

Certified-Expired

Received Date

2022-12-12

Decision Date

2023-11-15

Refile

N

Original File Date

2024-01-01 00:18:04

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MEDICAL DEVICE BUSINESS SERVICES, INC.

Employer Name Slug

medical-device-business-services-inc

Employer Address 1

700 ORTHOPAEDIC DRIVE

Employer Address 2

Employer City

WARSAW

Employer City Slug

warsaw

Employer State

INDIANA

Employer State Slug

indiana

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

46582

Employer Phone

574-372-7520

Employer Number of Employees

141700

Employer Year Commenced Business

1895

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Espinal Margaret

Employer Contact Address 1

One Johnson Johnson Plaza

Employer Contact Address 2

Employer Contact City

New Brunswick

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

8933

Employer Contact Phone

415-909-0983

Employer Contact Email

[email protected]

Agent Attorney Name

Fernanda Molina

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

469-505-2588

Agent Attorney Address 1

11 Times Square

Agent Attorney Address 2

11th floor

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10036

Agent Attorney Email

[email protected]

PW Track Number

P10021173419076

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

N/A

PW Wage

84930.00

PW Unit of Pay

Year

PW Wage Source

Other

PW Determination Date

2022-02-04

PW Expiration Date

2022-06-30

Wage Offer From

99600.00

Wage Offer To

109600.00

Average Salary

104600.00

Wage Unit of Pay

Year

Worksite Address 1

325 Paramount Drive

Worksite Address 2

Worksite City

Raynham

Worksite City Slug

raynham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2767

Job Title

Senior Quality Engineer

Job Title Slug

senior-quality-engineer

Minimum Education

Bachelor's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

36

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.14

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

36

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Employer will accept Bachelors degree in Scientific, Engineering, or related technical field and 3 years of work experience in job offered or 3 years of work experience in a positionrelated occupation. Experience may be gained concurrently. Any suitable combination of education, training, or experience is acceptable. Education or experience must includebr br 1. 2 years of Quality EngineeringProcess ExcellenceLean Manufacturing experience in highly regulated industry;br 2. Experience conducting ProcessDesign Failure Mode Effects and Analysis;br 3. Experience authoring and coordinating new master process validation plans for manufacturing transfers;br 4. Experience in operations and manufacturing of Class I and II Medical Devices;br 5. Medical product knowledgebr 6. Experience with Blueprint readingliteracy including GDT;br 7. Experience with inspection methods and techniques;br 8. Knowledge of the QSR, Design Controls, and ISO quality requirements;br 9. Bioinstrumentation and human anatomy experience to define functional, performance, usability and safety requirements of medical product according to the intended use;br 10. Statistical techniques and quality engineering skills needed for establishing and verifying the acceptability of process capability and medical product characteristics;br 11. Experience leading nonconformance NC and CAPA projects in highly regulated environment with minimal supervision;br 12. Experience managing productprocess improvement projects in high regulated environment with minimal supervision; andbr 13. Experience coordinating and conducting audit of external supplier quality performance.br br Some travel 10 may be required to work on projects at various, unanticipated sites throughout the United States to various JJ and Supplier Sites. May telecommute from home.

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

2022-06-19

SWA Job Order End Date

2022-07-19

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Herald

First Advertisement Start Date

2022-08-14

Second Newspaper Ad Name

Boston Herald

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-08-21

Employer Website From Date

2022-11-11

Employer Website To Date

2022-11-18

Professional Organization Ad From Date

2024-01-01 00:18:04

Professional Organization Advertisement To Date

2024-01-01 00:18:04

Job Search Website From Date

2022-07-01

Job Search Website To Date

2022-07-01

Employee Referral Program From Date

2024-01-01 00:18:04

Employee Referral Program To Date

2024-01-01 00:18:04

Local Ethnic Paper From Date

2022-08-25

Local Ethnic Paper To Date

2022-08-25

Radio/TV Ad From Date

2024-01-01 00:18:04

Radio/TV Ad To Date

2024-01-01 00:18:04

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

MALAYSIA

Foreign Worker Birth Country

MALAYSIA

Class of Admission

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

UNIVERSITY OF MINNESOTA

Foreign Worker Education Institution Address 1

TWIN CITIES CAMPUS

Foreign Worker Education Institution Address 2

222 PLEASANT ST SE

Foreign Worker Education Institution City

MINNEAPOLIS

Foreign Worker Education Institution State/Province

MN

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

55455

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Fernanda Molina

Preparer Title

Associate

Preparer Email

[email protected]

Employer Information Declaration Name

Margaret Espinal

Employer Information Declaration Title

Global Head of Immigration