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Embedded System Software Testing-Lead
Saint Paul, MN
Saint Paul
MN
55112
Date
: Dec-16-20
2020-12-16
2021-12-16
Embedded System Software Testing-Lead
Saint Paul, MN
Dec-16-20
Work Authorization
US Citizen
GC
H1B
EAD (OPT/CPT/GC/H4)
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect, Senior
Rate/Salary ($)
:
DOE
Duration
:
12 MONTHS
Sp. Area
:
C, C++, Middleware, Embedded
Sp. Skills
:
Embedded System
Consulting / Contract
CONTRACTOR
Required Skills
:
Agile, C, Documentum, Embedded, Risk Management, medical device manufacturing, a) Specification Development b) Test Method Development and Validation
Preferred Skills
:
Domain
:
HealthCare, Pharmaceuticals
Work Authorization
US Citizen
GC
EAD (OPT/CPT/GC/H4)
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect, Senior
Rate/Salary ($)
:
DOE
Duration
:
12 MONTHS
Sp. Area
:
C, C++, Middleware, Embedded
Sp. Skills
:
Embedded System
Consulting / Contract
CONTRACTOR
Required Skills
:
Agile, C, Documentum, Embedded, Risk Management, medical device manufacturing, a) Specification Development b) Test Method Development and Validation
Preferred Skills
:
Domain
:
HealthCare, Pharmaceuticals
Infoways
Trenton, NJ
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Job Description:
Prior medical device manufacturing background and experience required, coordinates with functional manager / SME to create CO and follow through same for closure .
Ability to review Design Validation /Specifications /documents /Drawings / Details Data collection in EU MDD / MDR Tech files
Hazard Analysis / Component Design FMEA / review /verification / Updates
Experience in Specification development, Agile, Documentum or any document management system
Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team.
Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary.
Communicate significant issues or developments identified during production, validation and qualification activities.
Knowledge on ISO 13485/Part 820 / ISO 14971 and prior Medtronic experience will be preferred.
Must have Skills:
a) Specification Development
b) Test Method Development and Validation
c) Design Verification and Validation
e) Design Input / Design Output Matrix
f) Change Management Process
Nice to Have Skills:
a) Experience with or Exposure to implantable / Tissue or Mechanical Heart Valves
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