Senior Manufacturing Engineer: Lead Continuous Improvement

Aurora Lifesciences; Leeds; On-site; GBP 55,000 - 75,000; Full time

Job summary

Aurora Lifesciences is seeking a Senior Manufacturing Engineer to own process improvement in a regulated medical device environment. You will work closely with Production, Quality and R&D to enhance manufacturing performance while ensuring ISO 13485 compliance.

You will analyse KPIs, lead process development and optimization, and apply Lean Six Sigma to reduce variation and increase capacity. This role emphasizes data-driven decisions and practical, shop-floor engineering leadership.

Qualifications

• Degree in Mechanical, Manufacturing, Biomedical Engineering or related field.
• 5+ years of engineering experience within medical devices or regulated manufacturing.
• Strong knowledge of ISO 13485 and regulated manufacturing.
• Experience with continuous improvement, root cause analysis and lean manufacturing.
• Experience with process validation and equipment qualification.
• Strong statistical and data-analysis capability.
• Experience improving manufacturing yield, capacity, efficiency or process capability.
• Lean Six Sigma Green Belt or equivalent advantageous.

Responsibilities

• Analyse manufacturing KPIs and data to identify opportunities for continuous improvement, increased throughput, improved yield and reduced waste.
• Lead manufacturing process development, optimisation, line balancing and capacity improvement activities.
• Conduct structured root cause analysis using tools such as 8D, DMAIC, Fishbone and 5 Whys.
• Apply lean manufacturing, Six Sigma and statistical techniques to reduce variation and improve process capability.
• Lead continuous improvement projects from problem identification through implementation and effectiveness review.
• Design and execute engineering trials, experiments and validation protocols, analysing results to support evidence-based decisions.
• Support CAPA, non-conformances, audit findings and manufacturing investigations.
• Develop work instructions, process documentation and training materials within an ISO 13485 compliant QMS.
• Coach engineers and technicians in problem solving, process control and engineering best practice.

Skills

Continuous improvement

Root cause analysis

Lean manufacturing

Six Sigma

Statistical analysis

Data analysis

Problem solving

Process validation

Equipment qualification

New equipment introduction

Coaching

Education

Mechanical, Manufacturing, Biomedical Engineering degree

Job description

Aurora Lifesciences is seeking a Senior Manufacturing Engineer to own process improvement in a regulated medical device environment. You will work closely with Production, Quality and R&D to enhance manufacturing performance while ensuring ISO 13485 compliance.

You will analyse KPIs, lead process development and optimization, and apply Lean Six Sigma to reduce variation and increase capacity. This role emphasizes data-driven decisions and practical, shop-floor engineering leadership.