Process Engineer – Additive Manufacturing & Validation (Medical)

Materialise; Vlaams-Brabant; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Materialise is seeking a Process Engineer to join the HQ Process Engineering team in Leuven. You will lead cross-functional teams on CMF product development and manufacturing process development, with a strong focus on additive manufacturing, validation, and process documentation.

You will own validation programs (IQOQPQ), assess manufacturability early in design, and drive scalable process improvements while collaborating with device development, quality, biosafety and regulatory teams.

Qualifications

• Master's degree in engineering required.
• At least 2 years of experience in a process (validation) engineering role within highly regulated industries such as medical devices, pharmaceuticals or aerospace.
• Experience with Design Transfer activities and/or Additive Manufacturing is a strong plus.
• Quality oriented with attention to detail, and ability to think outside the box when needed.
• Strong troubleshooting and problem-solving skills.
• Proactive, self-organized, with full ownership of tasks and excellent coordination.
• Strong English verbal and written skills.

Responsabilités

• Lead cross-functional agile teams focusing on CMF product development and manufacturing process development and implementation.
• Develop expertise in additive manufacturing, post-processing, cleaning and quality inspection technologies.
• Drive larger process development, implementation and validation projects with alignment across teams.
• Assess manufacturability and validation needs early in device development and assist in defining product specifications for validation.
• Own and execute validation programs (IQOQPQ) for manufacturing processes and equipment.
• Set up and analyze process characterization studies to understand parameter impact.
• Continuously evaluate process performance and drive standardization, automation and scalable improvements.
• Document process development and validation steps, including work instructions and training.

Connaissances

Troubleshooting

Problem solving

Proactive & organized

Quality orientation

Cross-functional collaboration

English communication

Formation

Master's degree in engineering

Outils

IQOQPQ validation

Additive Manufacturing

Design Transfer

Description du poste

Materialise is seeking a Process Engineer to join the HQ Process Engineering team in Leuven. You will lead cross-functional teams on CMF product development and manufacturing process development, with a strong focus on additive manufacturing, validation, and process documentation.

You will own validation programs (IQOQPQ), assess manufacturability early in design, and drive scalable process improvements while collaborating with device development, quality, biosafety and regulatory teams.