Senior Process Validation Engineer – Standard 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

At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment — helping improve and save lives daily.

Senior Process Validation Engineer – Standard Devices (CMF)

Location: Leuven, Belgium (HQ), with recurring extended travel to Rio Claro, Brazil

About the role

Materialise is a worldwide leader in patient-specific medical devices. In the Cranio-Maxillofacial (CMF) domain, we are scaling a second growth engine: standard, non-patient-specific implants and instruments, together with Materialise Brazil in Rio Claro.

To support this growth and ensure consistent process quality and control across both sites, we are looking for a Senior Process Validation Engineer to become the engineering link between our HQ and Brazil’s development and manufacturing sites.

What you will be doing

• You are a member of a cross-functional engineering team working on the development, validation and operational release of new and improved products and manufacturing processes, in close collaboration with our suppliers.

• You translate product and process requirements into validation strategies and process control programs, in close collaboration with product development, R&D, biosafety, quality and regulatory teams in both Leuven and Brazil.

• You take up a leading role in qualifying equipment, validating software, and supporting the technology transfer of processes as production responsibilities grow in Materialise Brazil.

• You monitor process performance, investigate deviations, and drive corrective and preventive actions across both sites.

• You spend recurring, extended periods on-site in Brazil to align the way of working and strengthen collaboration between both teams.

Your profile

• You have several years of hands-on experience in process validation within the medical device industry (or a comparably regulated environment).

• You are familiar with manufacturing processes such as milling, turning, anodizing, passivation, welding, laser cutting and/or ultrasonic cleaning.

• You are fluent in Portuguese and English — able to work independently and build trust with colleagues in both languages.

• You are willing to travel to and work from Brazil for extended periods on a recurring basis.

• You hold a master’s degree in Engineering (Industrial, Mechanical, Materials, Biomedical or related), or equivalent through experience.

• You are familiar with ISO 13485; knowledge of RDC 665 / ANVISA GMP and FDA concepts is a plus.

• You have a solid grasp of statistics and experience with risk analysis methodologies such as FMEA.

• You have strong communication skills and a proactive, quality-driven mindset, with good judgement on priorities.

What we offer

• A high-impact role connecting Materialise’s HQ Engineering team with growing activities in Materialise Brazil.

• A position based at our Leuven HQ, combined with recurring extended assignments in Materialise Brazil.

• Close collaboration with an international team spanning process engineering, R&D, quality and operations.

• A growth trajectory: as the scope of the role develops, so does the range of your responsibilities across our global operations.

What’s waiting for you

Work that matters

The technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it. No matter your role, we unlock new possibilities to build a better and healthier world every day.

At Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.

A people-centered space

When you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back.

At the same time, we expect you to invest in the people around you — not just your own work — to make the group stronger than the sum of its parts.

An environment of trust

As a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls.

At Materialise, we expect you to deliver on that trust and keep your commitments.

A career ready to build

When you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here.

At Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.

Make a difference together with the Medical team.