Global Process Validation Lead – Medical Devices (CMF)

Materialise NV; Belgique; À distance; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Materialise NV in Leuven is seeking a Senior Process Validation Engineer to bridge HQ engineering and Materialise Brazil in Rio Claro. You will validate and release new and improved manufacturing processes, coordinating with development, R&D, biosafety, quality, and regulatory teams across two continents.

The role requires leading equipment qualification, software validation, and technology transfer. Extensive travel to Brazil is expected, with a master’s degree in engineering and ISO 13485

Qualifications

• Several years of hands-on experience in process validation within the medical device industry.
• Familiar with manufacturing processes such as milling, turning, anodizing, passivation, welding, laser cutting and/or ultrasonic cleaning.
• Fluent in Portuguese and English; able to work independently across languages.
• Master’s degree in Engineering or equivalent.
• Familiar with ISO 13485; knowledge of RDC 665 / ANVISA GMP and FDA concepts is a plus.
• Solid grasp of statistics and risk analysis methodologies such as FMEA.

Responsabilités

• Develop validation strategies and control programs for new and improved products/processes across Leuven and Brazil.
• Qualify equipment, validate software, and support technology transfer as Brazil scales.
• Monitor process performance, investigate deviations, and implement CAPA across sites.
• Spend recurring extended periods on-site in Brazil to align ways of working and strengthen collaboration.

Connaissances

Process validation

Statistical analysis

FMEA

Communication

Travel readiness

Formation

Master's degree in Engineering

Outils

ISO 13485 familiarity

FDA concepts knowledge

Description du poste

Materialise NV in Leuven is seeking a Senior Process Validation Engineer to bridge HQ engineering and Materialise Brazil in Rio Claro. You will validate and release new and improved manufacturing processes, coordinating with development, R&D, biosafety, quality, and regulatory teams across two continents.

The role requires leading equipment qualification, software validation, and technology transfer. Extensive travel to Brazil is expected, with a master’s degree in engineering and ISO 13485