Senior Manufacturing Engineer: Process Optimization

Aurora Lifesciences; England; On-site; GBP 60,000 - 85,000; Full time

Job summary

Aurora Lifesciences in the United Kingdom is seeking a Senior Manufacturing Engineer to own manufacturing and process engineering activities, driving improvements in throughput, yield and process capability while maintaining ISO 13485 compliance.

You will work with Production, Quality and R&D, leading CI projects, running trials and validation, and coaching others to solve problems using data-driven decisions.

Qualifications

• 5+ years’ engineering experience in medical devices or regulated manufacturing.
• Experience with ISO 13485 and regulated manufacturing.
• Proven continuous improvement, root cause analysis, and lean manufacturing.
• Experience with process validation and equipment qualification.
• Strong statistical and data-analysis capability.
• Experience improving yield, capacity, efficiency or process capability.
• Lean Six Sigma Green Belt or equivalent advantageous.

Responsibilities

• Analyse KPIs and data to identify CI opportunities.
• Lead process development, optimisation, line balancing and capacity improvement.
• Use 8D, DMAIC, Fishbone and 5 Whys for root cause analysis.
• Apply lean, Six Sigma and statistical techniques to reduce variation.
• Lead CI projects from identification to implementation.
• Design and execute trials, experiments and validation protocols.
• Support CAPA, non-conformances, audits and investigations.
• Develop work instructions, documentation and QMS training.
• Coach engineers and technicians in problem solving and process control.

Skills

Data analysis

Lean manufacturing

Six Sigma

Root cause analysis

Statistical methods

Education

Engineering degree (Mechanical/Manufacturing/Biomedical)

Job description

Aurora Lifesciences in the United Kingdom is seeking a Senior Manufacturing Engineer to own manufacturing and process engineering activities, driving improvements in throughput, yield and process capability while maintaining ISO 13485 compliance.

You will work with Production, Quality and R&D, leading CI projects, running trials and validation, and coaching others to solve problems using data-driven decisions.