Process Engineer

IT WORLD LIMITED; Leeds; On-site; GBP 45,000 - 65,000; Full time

Job summary

IT WORLD LIMITED in Leeds seeks a hands-on Manufacturing Engineer with experience in medical device production and process validation. You will lead end-to-end establishment of manufacturing processes and drive optimization to improve efficiency, quality, and compliance.

The role requires knowledge of Six Sigma, Kaizen, Lean techniques and tools, plus expertise in MSA, SPC and DoEs. Validation support (IQ/OQ/PQ) and familiarity with ISO13485/ISO14971 are advantageous.

Qualifications

• Hands-on experience in process engineering within manufacturing.
• Experience with end-to-end establishment of manufacturing processes.
• Knowledge of Six Sigma, Kaizen, Lean techniques and improvement tools.
• Experience with Measurement System Analysis (MSA), SPC and Design of Experiments (DoEs).
• Familiarity with validation activities (IQ/OQ/PQ).
• Exposure to medical device manufacturing standards (ISO13485, ISO14971) - advantageous.
• Knowledge of cleaning and packaging processes.

Responsibilities

• Hands-on process engineering to establish and optimize manufacturing processes.
• Drive end-to-end support for establishing manufacturing processes.
• Lead optimization and efficiency improvements of processes.
• Support IQ/OQ/PQ validation activities.
• Apply Six Sigma, Kaizen, Lean methods to reduce variability and waste.

Skills

Process engineering

Manufacturing processes

Lean Six Sigma

Quality validation

Statistical methods (MSA, SPC)

DoEs

Reliability

Kaizen

5S/Continuous improvement

Tools

3D CAD software

Job description

• Hands on experience in process engineering in manufacturing industry
• End to end support for establishing manufacturing processes
• Optimization and efficiency improvement of processes
• Support IQ OQ PQ Validation
• Knowledge on various manufacturing processes in medical device manufacturing
• Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies are required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Exposure to ISO13485 and ISO14971 medical standards - Advantage
• Knowledge in cleaning and packaging process
• Knowledge of any 3D CAD software
• Strong Technical Knowledge in Manufacturing Engineering