Plant and Mechanical Engineering
Senior Process engineer
Eindhoven, Netherlands20% remoteFreelanceStart date 10/2025Duration 12 months12 months
InnovationSix Sigma MethodologyBiomedical EngineeringBusiness Process ImprovementGood Manufacturing PracticesChemical EngineeringCommercializationProcess EngineeringFood SafetyHealth CareHigh-Yield DebtProcess CapabilityProcess ControlQuality ManagementReproducibilityStatisticsRoot Cause AnalysisManufacturing ProcessesMedical MaterialIso StandardsRegulatory Affairs
Description
Senior Process Engineer - Contract (Medical Devices)
Location: Eindhoven, Netherlands
Contract Duration: 12 months
Working Hours: 40 hours per week
Work Mode: Primarily on-site, with limited hybrid flexibility
Our client is seeking a highly skilled Senior Process Engineer to join their team on a contract basis. This role is critical to supporting our manufacturing operations as we approach key regulatory milestones, including CE marking and commercialisation. You will work alongside experienced engineers to optimise and validate manufacturing processes and equipment, ensuring compliance with the highest industry standards.
Key Responsibilities:
Required Qualifications and Experience:
Desirable Skills:
Start Date:
Immediate availability preferred.
If you are a driven process engineer with a passion for innovation and quality in medical device manufacturing, we invite you to apply and transform patient care through advanced biomaterials.
Location: Eindhoven, Netherlands
Contract Duration: 12 months
Working Hours: 40 hours per week
Work Mode: Primarily on-site, with limited hybrid flexibility
Our client is seeking a highly skilled Senior Process Engineer to join their team on a contract basis. This role is critical to supporting our manufacturing operations as we approach key regulatory milestones, including CE marking and commercialisation. You will work alongside experienced engineers to optimise and validate manufacturing processes and equipment, ensuring compliance with the highest industry standards.
Key Responsibilities:
- Lead process improvement initiatives using Six Sigma methodologies to enhance equipment performance and process capability (PPK).
- Develop scalable, high-yield manufacturing processes with robust reproducibility.
- Troubleshoot and resolve process-related issues through structured root cause analysis.
- Execute validation activities in accordance with FDA and ISO regulations, including documentation preparation.
- Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to integrate new technologies and processes into production.
Required Qualifications and Experience:
- Bachelor's or Master's degree in Mechanical, Biomedical, or Chemical Engineering.
- Minimum 5 years of experience in process engineering within the medical device industry.
- Proven expertise in process validation and statistical analysis tools.
- Strong knowledge of FDA regulations, ISO standards, and GMP compliance.
- Fluent in English (written and spoken).
- Analytical, data-driven approach to problem-solving.
Desirable Skills:
- Experience with electrospinning technologies.
- Six Sigma Black Belt certification.
Start Date:
Immediate availability preferred.
If you are a driven process engineer with a passion for innovation and quality in medical device manufacturing, we invite you to apply and transform patient care through advanced biomaterials.