Validation Engineer Resume Bloomington, IN - Hire IT People

PROFESSIONAL EXPERIENCE

Validation Engineer

Confidential, Bloomington, IN

Responsibilities:

Primary manufacturing engineer responsible for production of 4 assembly lines (mattresses, 80 Long Term Care bed, 100 Low bed, and Progressa ICU bed).
Performed quality and compliance remediation efforts following FDA 483 letter
Created operator job instructions and 3 variable PFMEA for bed in pilot stage of production
Performed line rebalances on mattress lines and Progressa lines.
Processed engineering and document change requests using Agile Software

Clinical Engineering

Confidential, Cincinnati, OH

Responsibilities:

Created custom wheelchair traction attachments for pediatric spinal patients
Designed, prototyped and performed FAI on various medical devices
Investigated numerous medical device failures for root cause analysis
Implemented and helped troubleshoot RFID tracking system for medical equipment
Performed vendor reviews on medical devices for contract procurement
Performed item availability study to determine hospital needs per patient census