Validation Engineer

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

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.
• Apply 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.
• + years of manufacturing engineering experience (or + 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.