Senior Process Validation Engineer – Med Devices (Global)

Materialise; Vlaams-Brabant; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Materialise invites a Senior Process Validation Engineer to join the CMF standard devices initiative at our Leuven HQ, with extended assignments in Brazil. You will bridge engineering efforts between Europe and Brazil, ensuring robust validation and process control for scale‑up.

You will qualify equipment, validate software, and lead technology transfer as production expands in Brazil, while maintaining process performance and driving CAPA across sites.

Qualifications

• Hands-on experience in process validation in the medical device industry or a regulated environment.
• 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 Leuven and Brazil.
• Willing to travel to Brazil for extended periods.
• Master’s degree in Engineering (Industrial, Mechanical, Materials, Biomedical or related) or equivalent through experience.
• Knowledge of ISO 13485; RDC 665/ANVISA GMP and FDA concepts is a plus.
• Strong grasp of statistics and risk analysis methodologies such as FMEA.
• Strong communication skills and proactive, quality-driven mindset.

Responsabilités

• Develop, validate and release new and improved products and manufacturing processes in cross-functional team with suppliers.
• Translate product and process requirements into validation strategies and process control programs with HQ and Brazil teams.
• Qualify equipment, validate software, and support technology transfer as production grows in Brazil.
• Monitor process performance, investigate deviations, and drive CAPA across sites.
• Spend extended on-site time in Brazil to align working methods and collaboration.

Connaissances

Process validation

Manufacturing processes knowledge

Portuguese language

English language

Travel to Brazil

Communication skills

Statistics / FMEA

ISO 13485 knowledge

Formation

Master’s degree in Engineering

Description du poste

Materialise invites a Senior Process Validation Engineer to join the CMF standard devices initiative at our Leuven HQ, with extended assignments in Brazil. You will bridge engineering efforts between Europe and Brazil, ensuring robust validation and process control for scale‑up.

You will qualify equipment, validate software, and lead technology transfer as production expands in Brazil, while maintaining process performance and driving CAPA across sites.