Validation Engineer

Overview

On Site
Full Time

Skills

Risk Assessment
SOP
FMEA
RTM
Reporting
IQ
OQ
PQ
Test Execution
Test Methods
Minitab
GAMP
Data Integrity
Collaboration
Research and Development
Risk-based Testing
Manufacturing
Medical Devices
Adobe AIR
Printers
Assembly
Welding
Communication
Biomedical Engineering
Instrumentation
Electrical Engineering
Mechanical Engineering

Job Details

Job Description:
  • Author/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report.
  • Perform IQ/OQ/PQ test execution for manufacturing equipment.
  • Experience in Test Method Validation, Gage R&R, Minitab, and Process Validation.
  • Hands-on experience in GAMP 5, FDA 21 CFR Part 11, Data Integrity, ALCOA requirements.
  • In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211).
  • Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation requirements and risk-based testing strategies.
  • Investigate and resolve software or system-level issues found during validation or manufacturing use.
  • Experience in ATE system validation in the medical device industry.
  • Measurement System knowledge.
Hands-on experience with few of the below listed systems:
  • Ultrasonic Washer.
  • Barcode Scanner.
  • Bio-Burden Hood.
  • Auto Cannula Sorter.
  • Air Blockage Tester.
  • Lasermike / Bench Top Laser Mike.
  • Farrel Mixer Controller and Puller.
  • Puller/Cutter.
  • Rubber Slicer.
  • Extruder W/ Water bath.
  • Flow Tester.
  • Printex/ Zebra Printers/ Printronix Printer/ Image Pouch Printer.
  • Bladder Sorter Auto Machine.
  • Automatic Tube Set Assembly Machine.
  • Snap Cap Welding Machine.
  • Longford Labeler/ Universal Labeling System/ Labeling Machine.
  • Herrmann Welder.
  • Uson Leak Tester/Two Up Tester/Coiled Fill Port Tester.
  • Battery Simulator.
  • Battery Module Communication Test Fixture.
  • Keypad misuse test fixture.
Requirements:
  • Bachelor's or Master's in Biomedical Engineering, Instrumentation Engineering, Electrical Engineering, Measurement Engineering, Mechanical Engineering, or related field.
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