Agent/ Attorney Address Line 1:2400 N. Glenville Dr., Building A
Agent/ Attorney Address Line 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
Position Info
Prevailing Wage Track Number:P10020268844900
Prevailing Wage SOC Code :17-2031
Prevailing Wage SOC Title :Biomedical Engineers
Prevailing Wage Skill Level:Level III
Prevailing Wage:104624
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2021-02-26
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:123769
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:One Amgen Center Drive
Worksite Address Line 2:
Worksite City :Thousand Oaks
Worksite State:CALIFORNIA
Worksite Postal Code:91320
Job Title:Senior Engineer
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:See H.14
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :Y
Required Expreience Months :36
Accept Alternate Field of Study:N
Accept Alternate Major:
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:5
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:36
Accept Alternate Job Title:See H.14
Normal Requirements of Job Opportunity:N
Required Foreign Language: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 Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-03-18
Job Oder 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 Name:Los Angeles Daily News
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-04-11
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:2021-03-29
Pro.Org. Ad to Date:2021-04-05
Job Search Website from Date:2021-03-29
Job Search Website to Date:2021-04-05
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-04-07
Local Ethnic Newspaper to Date:2021-04-07
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:INDIA
Foreign Worker Birth Country:INDIA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:BIOENGINEERING
Year of Compelted Education:2013
Foreign Worker Istitution of Eduation:UNIVERSITY OF ILLINOIS AT CHICAGO
Foreign Worker Education Instution Address Line 1:1200 W HARRISON STREET
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:CHICAGO
Foreign Worker Educatution Institution State:IL
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:60607
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N
Foreign Worker Alternate Education and Experience :N
Foreign Worker Alternate Occupation Experience:Y
Foreign Worker Experience with Employer:N
Foreign Worker Employer Pay 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
