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Infoways
Trenton, NJ
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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