Senior Process Validation Engineer - Medical Devices (Global)

Mondeadditif; Heverlee; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Materialise Medical in Leuven, Belgium, is seeking a Senior Process Validation Engineer for the Cranio-Maxillofacial domain to link HQ engineering with Brazil development and manufacturing.

You will lead validation strategies, qualify equipment, validate software, and support technology transfer as production expands in Brazil, with extended on-site periods in Brazil to align ways of working and strengthen collaboration.

Qualifications

• Master’s degree in Engineering (Industrial, Mechanical, Materials, Biomedical or related) or equivalent.
• Experience in process validation within the medical device industry or a comparably regulated environment.
• Familiarity 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, validate and operationally release new and improved products and manufacturing processes.
• Translate product and process requirements into validation strategies in collaboration with development, R&D, biosafety, quality and regulatory teams.
• Qualify equipment, validate software, and support technology transfer as production grows in Brazil.
• Monitor process performance, investigate deviations, and drive CAPAs across sites.
• Spend recurring, extended periods on-site in Brazil to align ways of working and strengthen collaboration.

Connaissances

Process validation

Quality systems

Statistics

FMEA

Communication skills

Travel readiness

Formation

Master's degree in Engineering

Outils

ISO 13485

Regulatory knowledge (FDA/ANVISA)

Description du poste

Materialise Medical in Leuven, Belgium, is seeking a Senior Process Validation Engineer for the Cranio-Maxillofacial domain to link HQ engineering with Brazil development and manufacturing.

You will lead validation strategies, qualify equipment, validate software, and support technology transfer as production expands in Brazil, with extended on-site periods in Brazil to align ways of working and strengthen collaboration.