Process Engineer

Process Engineer

Materialise

Leuven, Belgium

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.