Process engineer

Blue Medical Devices is looking for an experienced Mid-Level / Senior Process Engineer who can analyse, improve and future-proof production processes within a highly regulated medical-device manufacturing environment.
You will improve process performance, product quality, reliability and efficiency. You translate production data, deviations and technical challenges into structural improvements and robust, validated processes.
You will work closely with Production, Engineering, R&D, QA/RA, QC and international colleagues within our parent company.
Your responsibilities   Analyse and improve production processes, yield, OEE, KPIs and process data.
Identify bottlenecks, risks and process deviations and implement structural solutions.
Perform root cause analyses, impact assessments, CAPAs and risk analyses.
Develop, optimise and embed new and existing production processes.
Prepare, execute and maintain process validations.
Prepare validation protocols, reports, work instructions and other technical documentation.
Manage change controls and assess and implement changes to processes, tooling and materials.
Contribute to process risk assessments and the verification of risk-control measures.
Support the transfer of new or modified processes and technologies into Operations.
Plan and execute improvement projects and subprojects and, depending on experience, lead them independently.
Perform statistical analyses and translate process data into practical improvement actions.
Provide solicited and unsolicited technical advice to Production, Quality and other stakeholders.
Document, share and transfer knowledge through training and coaching.
What we are looking for   At least 8 years of relevant experience as a Process Engineer, Manufacturing Engineer or in a comparable technical position.
For the senior level, typically more than six years of relevant experience and demonstrable experience with complex projects.
A completed bachelor’s or master’s degree in a technical discipline.

Experience with process development, process optimisation and problem-solving within a manufacturing environment.

Experience with process validation and preparing validation protocols and reports.
Knowledge of root cause analysis, CAPA, FMEA, risk management and change control.
Experience analysing process data, applying statistical methods and translating results into improvements.
Experience working within a Quality Management System and according to controlled procedures.
The ability to set priorities independently, take ownership and implement improvements successfully.
Good command of English, both written and spoken.
Good command of Dutch, or a genuine willingness to learn the language.
Full-time availability  and the willingness to work on-site in Helmond.
Preferred:

Experience with in medical devices, pharmaceuticals, hightech or another highly regulated manufacturing environment.
Knowledge of ISO 13485, MDR, GMP or comparable quality standards.

Experience with IQ, OQ, PQ, PPQ, cleanroom validation or sterilisation processes.

Experience with Minitab or comparable statistical software.
Lean Six Sigma Green Belt or Black Belt certification.

Experience with Design Transfer, material qualification or test-method validation.
Experience leading multidisciplinary improvement or validation projects.
For senior candidates: experience with stakeholder management, coaching and knowledge transfer.
What makes you successful?  You are analytical, quality-conscious and practically minded. You understand that a process improvement must not only work technically, but must also be controlled, validated and properly documented. You work in a structured manner, take ownership and communicate clearly. You are successful when processes become more stable and efficient, deviations are resolved structurally and projects demonstrably contribute to quality, output and reliability.
What we offer   A gross annual salary between  €60,000 and €80,000 , depending on your experience and the position level.
A one-year employment contract followed by a permanent contract, or an immediate permanent contract depending on your experience.
28 vacation days, in addition to all official Dutch…