Biocompatibility & Sterilization Engineer

Materialise NV; Vlaams-Brabant; On-site; EUR 65,000 - 95,000; Full time

Job summary

Materialise Medical in Belgium seeks a Biocompatibility Engineer to contribute to the biocompatibility evaluation and validation of cleaning, packaging, and sterilization processes for medical devices.

You will work with internal teams and external labs to ensure regulatory compliance and patient safety while developing robust validation protocols and supporting regulatory submissions.

Qualifications

• Master degree in engineering, biochemistry, biology, or medical field.
• Knowledge of regulatory requirements in biocompatibility, cleaning validation, packaging development, or sterilization validation of medical devices.
• Ability to manage multiple projects and establish short- and long-term planning horizons.
• Effective in a team and able to work independently to achieve goals.
• Clear and effective verbal communication and technical writing skills in English.
• Strong analytical skills and meticulous attention to detail.
• Passion for patient safety and customer satisfaction.

Responsibilities

• You ensure the biocompatibility of medical devices and validate cleaning, packaging, and sterilization processes.
• You support biological safety evaluations per ISO 10993-1 and validate cleaning and sterilization; you develop packaging for sterile and non-sterile devices and test performance.
• You plan and finalize validation protocols and reports, ensuring they are clear, concise, and compliant with instructions and standards.
• You coordinate tests with manufacturing teams and external labs to fulfill requirements.
• You act as an ambassador for biological safety within Materialise Medical and collaborate with internal and external partners.

Skills

Biocompatibility evaluation

Regulatory knowledge

Project management

Team collaboration

English communication

Education

Master's degree

Job description

Materialise Medical in Belgium seeks a Biocompatibility Engineer to contribute to the biocompatibility evaluation and validation of cleaning, packaging, and sterilization processes for medical devices.

You will work with internal teams and external labs to ensure regulatory compliance and patient safety while developing robust validation protocols and supporting regulatory submissions.