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• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 31st Dec 2020

Role : Embedded System
Location : Mounds View Minnesota

Contract Position

Client is not accepting  OPT/CPT/H1B for this role

Below is the 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

Kumar Sri Bharath