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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
Location and type of contract
Leuven, Belgium
Engineering
Hybrid
Full-time
Mid-senior
CV in English
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