Validation Engineer

North Haven, CT, US • Posted 6 hours ago • Updated 6 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Manufacturing Operations
Management
Mechanical Engineering
Root Cause Analysis
Lean Methodology
Corrective And Preventive Action
Regulatory Compliance
Robotics
Motion Control
Machine Vision
Statistics
Process Control
Design Of Experiments
Inspection
PPAP
Electrical Engineering
Mechatronics
Manufacturing Engineering
Medical Devices
IQ
OQ
PQ
Minitab
Manufacturing
Assembly

Summary

Job Summary:

Validation Engineer - Manufacturing Operations responsible for overseeing complex production processes for surgical devices, leading validation activities, troubleshooting electro-mechanical systems, and ensuring manufacturing efficiency, compliance, and quality standards.

Roles & Responsibilities:

Oversee and optimize complex production processes for surgical devices to meet efficiency and quality standards.
Serve as the primary technical expert for electro-mechanical equipment issues, perform root cause analysis, and implement corrective actions to reduce downtime.
Lead development and execution of validation strategies including IQ/OQ/PQ for new and existing equipment.
pply Lean principles to identify waste reduction and improve process stability.
Lead NCMR and CAPA investigations to maintain quality system compliance.
Support adaptation of machine/equipment design to production and factory conditions.
Troubleshoot automated systems including robotics, motion control, and machine vision.
Perform statistical analysis such as process capability, process control, DOE, and inspection design.
Ensure component qualification using PPAP methodologies.

Education & Experience:

Bachelor's degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
10+ years of manufacturing engineering experience (or 8+ years with a Master's degree).
Strong expertise in medical device process validation (IQ/OQ/PQ), statistical tools such as Minitab, and high-volume manufacturing assembly.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 5b702d5332f83aedb80b1a1b60183fb
Posted 6 hours ago

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Validation Engineer

Dice Job Match Score™

Job Details

Skills

Summary

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