Process Engineer
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About the Role
We're working with a growing medical technology business that is looking to add a Process Engineer to its team.
This is a great fit for someone who enjoys being close to the manufacturing process - developing new processes, solving problems, improving production and helping move products from development into manufacturing.
What You'll Be Doing
Develop and optimise manufacturing processes.
Support NPI and technology transfer from development into production.
Improve process capability, efficiency, yield and quality.
Define and monitor critical process parameters.
Support process validation and equipment qualification.
Lead investigations into deviations and manufacturing issues.
Contribute to CAPAs and change controls.
Introduce and optimise new equipment and manufacturing technologies.
Drive continuous improvement across manufacturing.
Use data, statistics and DoE to understand and improve processes.
Work closely with R&D, Production, Quality, Regulatory and Supply Chain.
Maintain the technical documentation required within a regulated manufacturing environment.
What You'll Bring
Engineering degree - Mechanical, Industrial, Biomedical, Chemical or similar.
Previous manufacturing / process engineering experience.
Experience improving and optimising production processes.
Strong problem-solving and analytical skills.
A hands-on approach and the ability to work across engineering and production.
Good understanding of process control and manufacturing documentation.
Ideally, You'll Also Have
Medical device or other regulated industry experience.
Process validation / equipment qualification experience.
CAPA, change control or non-conformance experience.
Lean / Kaizen / 5S / TPM experience.
DoE and statistical analysis experience.
SolidWorks or similar CAD experience.
Languages
Spanish & English – C1 / Advanced level
English will be used regularly across meetings, technical discussions, training and documentation with international teams.
If this sounds like you please get in touch with daniel.farag@established-search.com