Process Validation Engineer
Materialise Medical pioneers many leading medical applications of 3D printing, enabling researchers, engineers, and clinicians to revolutionize personalized treatments that help improve and save lives. In the cranio-maxillofacial (CMF) field, we develop and offer a comprehensive range of patient-specific surgical guides and implants to a growing and diversifying global customer base. To further drive and support our medical production activities, we're looking for a Process Validation Engineer to join our Process Engineering team at HQ in Leuven, Belgium.
What you will do
- Step into an international, cross-functional agile team that focuses on CMF product development and the corresponding process characterization, development, and implementation.
- Your engineering mindset allows you to build thorough expertise in additive manufacturing, post-processing, and quality inspection technologies, allowing you to become the go-to for process-related topics within the agile team.
- Identify, define, and implement new processes or process improvements. Data collected in both validation and operational settings allow you to continuously improve the operational quality and efficiency of our processes.
- Maintain existing and create new process validation programs in close collaboration with the product development, biosafety, and R&D teams. Identify, define, and execute new equipment validations. Translate this into operational success by providing the right process documentation (work instructions), operator training, and support.
- Set up, execute, and analyze process characterization studies to understand the impact of process parameters on process and product output.
- Guarantee compliance with QMS requirements by documenting all phases of the process characterization, implementation, and validation per internal procedures.
- As a member of the process engineering team, you will work closely 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 or equivalent through experience
- You have initial experience working on process validation in a professional setting
- You have a strong interest in the medical device industry
- You are quality-oriented and have an eye for detail, but you also don’t get stuck on this
- You have a strong, versatile, and proactive work ethic, and you’re eager to learn.
- You are good at troubleshooting and problem-solving
- Strong English verbal and written skills required
What we offer
Location and type of contract
- Leuven, Belgium
- Engineering
- Full-time
- Hybrid
- Associate level
- CV in English
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Working at Materialise
Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.
As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.