Senior Medical Device Process Excellence Engineer

Aurora Lifesciences; West Yorkshire; On-site; GBP 50,000 - 70,000; Full time

Job summary

Aurora Lifesciences in West Yorkshire is seeking a Senior Manufacturing Engineer to drive process improvements in a regulated medical device manufacturing environment. You’ll own manufacturing and process engineering activities, working with Production, Quality and R&D to enhance performance while maintaining ISO 13485 compliance.

You’ll analyze KPIs, lead process development and capacity upgrades, perform root-cause analysis with 8D, DMAIC, Fishbone and 5 Whys, and apply Lean Six Sigma to

Qualifications

• A degree in Mechanical, Manufacturing, Biomedical Engineering or a related discipline.

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

Root cause analysis

Lean manufacturing

Six Sigma

Data analysis

Process optimization

CAPA

ISO 13485 knowledge

Education

Mechanical Engineering

Manufacturing Engineering

Biomedical Engineering

Tools

Statistical methods

Job description

Aurora Lifesciences in West Yorkshire is seeking a Senior Manufacturing Engineer to drive process improvements in a regulated medical device manufacturing environment. You’ll own manufacturing and process engineering activities, working with Production, Quality and R&D to enhance performance while maintaining ISO 13485 compliance.

You’ll analyze KPIs, lead process development and capacity upgrades, perform root-cause analysis with 8D, DMAIC, Fishbone and 5 Whys, and apply Lean Six Sigma to