Senior Manufacturing Engineer

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

If you’re a Senior Manufacturing Engineer who gets satisfaction from improving how things are made, solving difficult production problems and using data to make better engineering decisions, this role should appeal.

As a Senior Manufacturing Engineer, you’ll work within an established medical device manufacturing environment where the focus is firmly on improving processes, increasing capacity, reducing variation and creating robust, scalable manufacturing solutions.

This isn’t a role where you’ll simply maintain existing processes. You’ll be expected to challenge them.

The Role

You’ll take ownership of manufacturing and process engineering activities, working closely with Production, Quality and R&D to improve manufacturing performance while maintaining compliance with ISO 13485 and wider medical device requirements.

As a Senior Manufacturing Engineer, your responsibilities will include:

• Analyse manufacturing KPIs and production 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.

The successful Senior Manufacturing Engineer will be comfortable spending time close to production, understanding what the data is showing and translating that information into practical improvements.

Education and Experience

• A degree in Mechanical, Manufacturing, Biomedical Engineering or a related discipline.
• 5+ years’ engineering experience within medical devices or a comparable highly regulated manufacturing environment.
• Strong practical knowledge of ISO 13485 and regulated manufacturing.
• Demonstrable experience of 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 manufacturing yield, capacity, efficiency or process capability.
• Lean Six Sigma Green Belt or equivalent experience would be advantageous.

This would particularly suit a Senior Manufacturing Engineer who enjoys questioning existing processes, identifying where performance can be improved and building solutions based on evidence rather than assumption.

You’ll need to be pragmatic, technically credible and comfortable influencing people across Manufacturing, Quality and Engineering.

If you’re a Senior Manufacturing Engineer with a genuine passion for process improvement and want a role where your decisions can have a visible impact on manufacturing performance, this is an opportunity to take real ownership of improvement within a regulated medical device environment