Process Engineer – Additive Manufacturing & Validation

MAT CZE Materialise SRO; Vlaams-Brabant; On-site; EUR 55,000 - 85,000; Full time

Job summary

Materialise Medical is seeking a Process Engineer to join the HQ Process Engineering team in Leuven. You will drive cross-functional development and validation of CMF manufacturing processes, linking product requirements to process needs.

You will own validation programs (IQOQPQ) for new and updated processes, conduct characterization studies, and ensure QMS compliance while collaborating with device development, biosafety, quality and regulatory teams.

Qualifications

• Master's degree in engineering is required.
• At least 2 years in a process (validation) engineering role in regulated industries.
• Experience with Design Transfer and/or Additive Manufacturing is a plus.
• Quality oriented with attention to detail and problem solving.

Responsibilities

• Lead cross-functional agile projects for process development and validation.
• Develop and implement CMF manufacturing processes with design transfer in mind.
• Create and manage validation programs (IQOQPQ) for new or updated processes.
• Setup process characterization studies to understand parameter impacts.
• Document work instructions and train operators to ensure compliance.
• Ensure Quality Management System compliance across validation activities.
• Collaborate with device development, biosafety, R&D, quality and regulatory teams.

Skills

Process engineering

Validation engineering

Quality assurance

Troubleshooting

Cross-functional collaboration

Education

Master's degree in engineering

Tools

IQOQPQ

Job description

Materialise Medical is seeking a Process Engineer to join the HQ Process Engineering team in Leuven. You will drive cross-functional development and validation of CMF manufacturing processes, linking product requirements to process needs.

You will own validation programs (IQOQPQ) for new and updated processes, conduct characterization studies, and ensure QMS compliance while collaborating with device development, biosafety, quality and regulatory teams.