Validation Engineer Medical Devices Manufacturing Systems

Job Title: Validation Engineer Medical Devices Manufacturing Systems
Job Position Location- Skaneateles Falls, NY

No. of opening: 1

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 W/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