Senior Process Validation Engineer – Medical Devices (CMF)

Materialise; Vlaams-Brabant; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

High-impact role connecting HQ with a/

Base at Leuven HQ with recurring trips

Collaboration with international team

Growth opportunities

Job summary

Materialise in Leuven, Belgium, is hiring a Senior Process Validation Engineer for Standard Devices (CMF) to bridge our Leuven HQ with Brazil development and manufacturing sites. You will lead validation strategies, qualify equipment, and support technology transfer as activities expand in Brazil.

This role requires hands-on experience in medical device process validation, familiarity with machining and finishing processes, and strong statistical and risk-analysis skills.

Qualifications

• Several years of hands-on experience in process validation within the medical device industry (or a comparably 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 and build trust with colleagues in both languages.
• Willing to travel to and work from Brazil for extended periods on a recurring basis.
• Master’s degree in Engineering (Industrial, Mechanical, Materials, Biomedical or related), or equivalent through experience.
• Familiar with ISO 13485; knowledge of RDC 665 / ANVISA GMP and FDA concepts is a plus.
• Solid grasp of statistics and experience with risk analysis methodologies such as FMEA.
• Strong communication skills and a proactive, quality-driven mindset, with good judgement on priorities.

Responsibilities

• Member of a cross-functional engineering team working on development, validation and operational release of new and improved products and processes.
• Translate product and process requirements into validation strategies and control programs with teams in Leuven and Brazil.
• Lead the qualification of equipment, software validation, and support technology transfer as Brazil grows.
• Monitor process performance, investigate deviations and drive CAPA across sites.
• Spend recurring, extended periods on-site in Brazil to align ways of working and strengthen collaboration.

Skills

Process validation

Medical devices experience

Statistical methods

Risk analysis (FMEA)

Cross-functional collaboration

Education

Master's degree in Engineering (Industrial, Mechanical, Materials, Biomedical or related)

Tools

FMEA

Statistical analysis software

Job description

Materialise in Leuven, Belgium, is hiring a Senior Process Validation Engineer for Standard Devices (CMF) to bridge our Leuven HQ with Brazil development and manufacturing sites. You will lead validation strategies, qualify equipment, and support technology transfer as activities expand in Brazil.

This role requires hands-on experience in medical device process validation, familiarity with machining and finishing processes, and strong statistical and risk-analysis skills.