Process Engineer

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

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.
To further drive & support our Medical Production activities Materialise Medical is looking for a Process Engineer to join the HQ Process Engineering team (Leuven).

What You Will Be Doing

• You will be stepping into a cross-functional agile team which focuses on CMF product development as well as manufacturing process development and implementation.
• With your strong engineering mindset, you develop thorough expertise in additive manufacturing, post-processing, cleaning and quality inspection technologies, allowing you to become the technical expert and GoTo for both development & operational questions. Next to that, you also gain a solid understanding of CMF product specifics, enabling you to effectively connect product requirements to the corresponding process needs.
• You take the lead in managing and driving larger process development, implementation and validation projects, ensuring alignment across different teams and timely delivery of results.
• You are involved early in the development of new or updated devices, assessing manufacturability and process validation needs. In close collaboration with the device development team, you assist in the definition of a clear and comprehensive set of product specifications which will serve as input for the process validation and implementation after design transfer.
• You own the validation programs for the manufacturing processes and corresponding equipment. You create these validation programs from scratch for new products and processes or update them for each product and process change, after which you execute (or coordinate the execution of) the corresponding equipment validations (IQOQPQ).
• Where required for process or product changes, you set up, execute and analyze process characterization studies to understand the impact of process parameters on process and product output.
• You continuously evaluate process performance and identify opportunities to standardize, streamline and automate process steps, contributing to operational excellence and scalability. You drive process development and operational roll-out of various process changes and translate this into operational success by providing the right process documentation, including work instructions, operator training and support.
• You guarantee compliance with Quality Management System requirements by meticulously documenting all phases of the process characterization, validation and operational implementation per internal quality procedures.
  

As a member of the Process Engineering team, you will enjoy close cooperation with stakeholders from operational, device development, biosafety, research, quality and regulatory teams. Through involvement in a variety of activities and projects, we set up a growth trajectory in which you can shape your own future within Materialise.

Your profile

• You have a master's degree in engineering
• You have at least 2 years of experience working in a process (validation) engineering role within highly regulated industries such as the medical devices, pharmaceuticals or aerospace industries. Experience with Design Transfer activities and/or Additive Manufacturing is considered a strong plus
• You are quality oriented and have an eye for detail, but you also don't get stuck on this. You are able to think out of the box when needed
• You are good at troubleshooting and problem solving
• You have a strong and versatile work ethic and you're eager to learn
• You are proactive and self-organized. You take initiative and demonstrate full ownership of your tasks.
• You value and uphold impeccable coordination
• Strong English verbal & written skills required
  

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 your 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.