Process Engineer

MAT CZE Materialise SRO; Vlaams-Brabant; On-site; EUR 55,000 - 85,000; Full time

Job summary

Materialise Medical is seeking a Process Engineer to join the HQ Process Engineering team in Leuven. You will drive cross-functional development and validation of CMF manufacturing processes, linking product requirements to process needs.

You will own validation programs (IQOQPQ) for new and updated processes, conduct characterization studies, and ensure QMS compliance while collaborating with device development, biosafety, quality and regulatory teams.

Qualifications

• Master's degree in engineering is required.
• At least 2 years in a process (validation) engineering role in regulated industries.
• Experience with Design Transfer and/or Additive Manufacturing is a plus.
• Quality oriented with attention to detail and problem solving.

Responsibilities

• Lead cross-functional agile projects for process development and validation.
• Develop and implement CMF manufacturing processes with design transfer in mind.
• Create and manage validation programs (IQOQPQ) for new or updated processes.
• Setup process characterization studies to understand parameter impacts.
• Document work instructions and train operators to ensure compliance.
• Ensure Quality Management System compliance across validation activities.
• Collaborate with device development, biosafety, R&D, quality and regulatory teams.

Skills

Process engineering

Validation engineering

Quality assurance

Troubleshooting

Cross-functional collaboration

Education

Master's degree in engineering

Tools

IQOQPQ

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.

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

Note: A motivation letter is requested when applying for this position.

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.

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