Fiscal Year

2022

Case Number

A-21186-12283

Case Status

Certified-Expired

Received Date

2021-08-01

Decision Date

2022-02-18

Refile

N

Original File Date

2022-01-01 10:58:04

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

COVIDIEN

Employer Name Slug

covidien

Employer Address 1

A MEDTRONIC COMPANY

Employer Address 2

710 MEDTRONIC PARKWAY LC300

Employer City

FRIDLEY

Employer City Slug

fridley

Employer State

MINNESOTA

Employer State Slug

minnesota

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

55432

Employer Phone

763-505-2710

Employer Number of Employees

7647

Employer Year Commenced Business

1960

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Lisa M Pedrys

Employer Contact Address 1

710 Medtronic Parkway NE, LC300

Employer Contact Address 2

Employer Contact City

Fridley

Employer Contact State/Province

MINNESOTA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

55432

Employer Contact Phone

763-505-2710

Employer Contact Email

Lisa.Marie.Pedrys@Medtronic.com

Agent Attorney Name

Loan T Huynh

Agent Attorney Firm Name

Fredrikson Byron, P.A.

Agent Attorney Phone

6124927165

Agent Attorney Address 1

200 South Sixth Street

Agent Attorney Address 2

Suite 4000

Agent Attorney City

Minneapolis

Agent Attorney State/Province

MINNESOTA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

550421425

Agent Attorney Email

lhuynh@fredlaw.com

PW Track Number

P10020230771680

PW SOC Code

17-2141

PW SOC Title

Mechanical Engineers

PW Skill Level

Level II

PW Wage

78728.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-03-12

PW Expiration Date

2021-06-30

Wage Offer From

92000.00

Wage Offer To

0.00

Average Salary

92000.00

Wage Unit of Pay

Year

Worksite Address 1

5920 Longbow Drive

Worksite Address 2

Worksite City

Boulder

Worksite City Slug

boulder

Worksite State

COLORADO

Worksite Postal Code

80301

Job Title

Sr. Post Market Vigilance Specialist

Job Title Slug

sr-post-market-vigilance-specialist

Minimum Education

Master's

Major Field of Study

Mechanical Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Industrial or Biomedical Engineering

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

12

Accept Alternative Job Title

experience in quality engineering for medical devices

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Requires a Masters degree in Mechanical, Industrial, or Biomedical Engineering and one 1 year of experience in quality engineering for medical devices. Must possess a minimum of one 1 year of experience with each of the following FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, and ISO 13485 for adverse event reporting requirements, and ISO14971; Corrective and Preventive Actions CAPA, Eight Disciplines 8D and design of experiments DOE, Design Failure Mode and Effect Analysis DFMEA; computer and software programs, database management, Business Objects, statistical analysis and trending analysis including Global Complaint Handling GCH, SAP production modules, Agile systems, and Clinical Risk Assessment; clinical and technical knowledge of Airways and Monitoring products including US Medical Device Reporting, EU Medical Device Vigilance, Manufacturers Incidents Reporting for EU, product recalls, and Field Corrective Actions for Airways and Monitoring products; Finite element analysis FEA on mechanical components; and Lean Sigma and Six Sigma, and Statistical analysis Minitab.

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

2021-04-19

SWA Job Order End Date

2021-05-19

Sunday Edition Newspaper

Y

First Newspaper Name

Daily Camera Boulder

First Advertisement Start Date

2021-04-25

Second Newspaper Ad Name

Daily Camera Boulder

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-05-02

Employer Website From Date

2021-04-19

Employer Website To Date

2021-06-19

Professional Organization Ad From Date

2022-01-01 10:58:04

Professional Organization Advertisement To Date

2022-01-01 10:58:04

Job Search Website From Date

2022-01-01 10:58:04

Job Search Website To Date

2022-01-01 10:58:04

Employee Referral Program From Date

2021-04-19

Employee Referral Program To Date

2021-05-03

Local Ethnic Paper From Date

2021-04-29

Local Ethnic Paper To Date

2021-04-29

Radio/TV Ad From Date

2022-01-01 10:58:04

Radio/TV Ad To Date

2022-01-01 10:58:04

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

MECHANICAL ENGINEERING

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

CLEVELAND STATE UNIVERSITY

Foreign Worker Education Institution Address 1

2121 EUCLID AVE.

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CLEVELAND

Foreign Worker Education Institution State/Province

OH

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

44115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Loan T Huynh

Preparer Title

Attorney

Preparer Email

lhuynh@fredlaw.com

Employer Information Declaration Name

Lisa M Pedrys

Employer Information Declaration Title

Director, Medtronic Immigration Solutions Team