What you will do
* Step into 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 develop thorough expertise in additive manufacturing, post-processing, cleaning, and quality inspection technologies, allowing you to become the technical expert and go-to for 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
* Become involved early in the development of new or updated devices, assessing manufacturability and process validation needs
* Assist in the definition of a clear and comprehensive set of product specifications in close collaboration with the device development team, which will serve as input for the process validation and implementation after design transfer
* Own the validation programs for manufacturing processes and corresponding equipment. 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)
* Set up, execute, and analyze process characterization studies as required for process or product changes 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 closely cooperate with stakeholders from operational, device development, biosafety, research, quality, and regulatory teams
* Through involvement in a variety of activities and projects, we will establish a growth trajectory that allows you to 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 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 have a proven ability to manage multiple projects and drive initiatives from concept to implementation
* You value and uphold impeccable coordination
* Strong English verbal and written skills required
* Note: a motivation letter is requested when applying for this position
Location and type of contract
* Leuven, Belgium
* Engineering
* Hybrid
* Full-time
* Associate
* CV in English