Validation Engineer - Medical Device Manufacturing & Lean

Katalyst HealthCares & Life Sciences; North Haven (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst HealthCares & Life Sciences is seeking a Validation Engineer in North Haven, Connecticut, responsible for overseeing production processes for surgical devices. The role involves leading validation activities, ensuring compliance with quality standards, and troubleshooting complex electro-mechanical systems.

The ideal candidate will hold a Bachelor's degree in Electrical Engineering or a related field, possess experience in manufacturing engineering, and demonstrate expertise in process validation methodologies.

Qualifications

• 3+ years of manufacturing engineering experience or equivalent experience with a Master's degree.
• Strong expertise in medical device process validation (IQ/OQ/PQ).

Responsibilities

• Oversee and optimize complex production processes for surgical devices.
• Lead development and execution of validation strategies for new and existing equipment.
• Troubleshoot automated systems including robotics and motion control.

Skills

Process validation

Statistical analysis

Lean principles

Root cause analysis

Education

Bachelor's degree in Electrical Engineering or related field

Tools

Minitab

Job description

Katalyst HealthCares & Life Sciences is seeking a Validation Engineer in North Haven, Connecticut, responsible for overseeing production processes for surgical devices. The role involves leading validation activities, ensuring compliance with quality standards, and troubleshooting complex electro-mechanical systems.

The ideal candidate will hold a Bachelor's degree in Electrical Engineering or a related field, possess experience in manufacturing engineering, and demonstrate expertise in process validation methodologies.