- Materialise
- Leuven, Belgium (Remote)
- Full-time
Process Validation Engineer
- Materialise
Leuven, Belgium
Full-time
Published:
- Materialise
Leuven, Belgium
Full-time
Published:
ABOUT US:
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:
YOUR PROFILE:
LOCATION AND TYPE OF CONTRACT:
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.
LOCATION AND TYPE OF CONTRACT:
- Leuven, Belgium;
- Engineering;
- Full-time;
- Hybrid;
- Associate level;
- CV in English.
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