Manufacturing Engineer

SMARTEDGE IT SERVICES PRIVATE LIMITED; Leeds; On-site; GBP 40,000 - 60,000; Full time

Job summary

SMARTEDGE IT SERVICES PRIVATE LIMITED is seeking a hands-on Manufacturing Process Engineer to support and establish manufacturing processes in a medical device environment. The role emphasizes process optimization, validation support, and adherence to quality standards.

The ideal candidate brings experience in process engineering for manufacturing, knowledge of Six Sigma/Lean tools, and familiarity with ISO13485/ISO14971. Knowledge of cleaning, packaging, and CAD software will be advantageous.

Qualifications

• Hands-on experience in process engineering in manufacturing industry.
• End-to-end support for establishing manufacturing processes.
• Experience in optimizing and improving process efficiency.
• Support IQ OQ PQ validation activities.
• Knowledge of manufacturing processes in medical device manufacturing.
• Familiarity with Six Sigma, Kaizen, Lean techniques.
• Training in statistics, Lean and Six Sigma with MSA, SPC, DOEs, reliability.
• Exposure to ISO13485 and ISO14971 standards is a plus.
• Knowledge of cleaning and packaging processes.
• Awareness of 3D CAD software and its application in manufacturing.
• Strong technical knowledge in manufacturing engineering.

Skills

Process engineering

End-to-end process setup

Process optimization

IQOQ/PQ validation

Medical device processes

Six Sigma / Kaizen / Lean

Statistics & DOE

ISO13485 awareness

ISO14971 awareness

Cleaning & packaging

Manufacturing engineering

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