Senior Manufacturing Process Engineer - Medical Devices

Aurora Life Sciences; Leeds; On-site; GBP 70,000 - 90,000; Full time

Job summary

Aurora Life Sciences in Leeds is seeking a Senior Manufacturing Engineer to drive process improvements in a regulated medical device environment. You’ll own manufacturing and process engineering activities, collaborating with Production, Quality and R&D to boost throughput, yield and capability while maintaining ISO 13485 compliance.

The role emphasizes data-driven decisions, root-cause analysis, and structured trials.

Qualifications

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

Responsibilities

• Analyse manufacturing KPIs and production data to identify opportunities for improvement.
• Lead process development, optimisation, line balancing and capacity improvement.
• Conduct structured root cause analysis using 8D, DMAIC, Fishbone and 5 Whys.
• Apply lean manufacturing, Six Sigma and statistical techniques to reduce variation.
• Lead continuous improvement projects from identification through implementation and review.
• Design and execute engineering trials, experiments and validation protocols.
• Support CAPA, non-conformances, audit findings and investigations.
• Develop work instructions, process documentation and training materials within ISO 13485 QMS.
• Coach engineers and technicians in problem solving and process control.

Skills

Data analysis

Root cause analysis

Process improvement

Statistical methods

Lean manufacturing

Continuous improvement

Education

Mechanical/ Manufacturing/ Biomedical Engineering degree

Tools

DMAIC

8D

Fishbone diagram

5 Whys

Job description

Aurora Life Sciences in Leeds is seeking a Senior Manufacturing Engineer to drive process improvements in a regulated medical device environment. You’ll own manufacturing and process engineering activities, collaborating with Production, Quality and R&D to boost throughput, yield and capability while maintaining ISO 13485 compliance.

The role emphasizes data-driven decisions, root-cause analysis, and structured trials.