Process Engineer

Process Engineer

Materialise

Leuven, Belgium

What you will do

• Join a cross-functional agile team that focuses on CMF product development, as well as manufacturing process development and implementation;
• With your strong engineering mindset, you'll develop thorough expertise in additive manufacturing, post-processing, cleaning, and quality inspection technologies, allowing you to become the technical expert and go-to for both development and operational questions;
• Gain a solid understanding of CMF product specifics, enabling you to effectively connect product requirements to the corresponding process needs;
• Take the lead in managing and driving larger process development, implementation, and validation projects, ensuring alignment across different teams and timely delivery of results;
• Get 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 process validation and implementation after design transfer;
• Own the validation programs for the manufacturing processes and corresponding equipment — create them 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);
• Set up, execute, and analyze process characterization studies to understand the impact of process parameters on process and product output;
• Continuously evaluate process performance and identify opportunities to standardize, streamline, and automate process steps, contributing to operational excellence and scalability;
• 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;
• 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 4 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 think out of the box when needed;
• You are good at troubleshooting and problem-solving;
• You have a strong and versatile work ethic and are eager to learn;
• You are proactive and self-organized; you take initiative and demonstrate full ownership of your tasks;
• You have a proven ability to manage multiple projects and drive initiatives from concept to implementation;
• You value and uphold impeccable coordination;
• Strong verbal and written English skills required;
• Note: a motivation letter is requested when applying for this position.