Biosafety Engineer - Medical Devices & Sterilization

Materialise; Vlaams-Brabant; On-site; EUR 55,000 - 75,000; Full time

Job summary

Materialise Belgium, part of Materialise Medical, seeks a highly qualified biocompatibility-focused engineer to drive validation and regulatory work for medical devices. You will work across cleaning, packaging, and sterilization processes, and support ISO 10993-1 assessments.

You will collaborate with Quality, Regulatory, Development, Process Engineering, and Manufacturing teams, build validation protocols, and contribute to regulatory submissions while staying compliant with work instructions.

Qualifications

• Master degree in engineering, biochemistry, biology or medical field.
• Knowledge of regulatory requirements and guidance for biocompatibility, cleaning validation, packaging or sterilization validation.
• Ability to manage multiple projects, set priorities and plan ahead.
• Independent decision making and teamwork to meet goals.
• Clear verbal communication and strong technical writing in English.
• Analytical mindset and meticulous attention to detail.
• Passion for patient safety and customer satisfaction.

Responsibilities

• Support biocompatibility evaluations per ISO 10993-1 and validate cleaning and sterilization processes.
• Develop and optimize packaging for sterile and non-sterile devices and test performance.
• Create and finalize validation protocols and reports, ensuring clarity and compliance.
• Plan test concepts with manufacturing and suppliers; coordinate external test labs.
• Collaborate with Quality, Regulatory, Development, Process Engineering and Manufacturing teams to ensure swift collaboration.
• Act as an ambassador for biological safety within Materialise Medical.

Skills

Teamwork

English communication

Analytical skills

Regulatory understanding

Biocompatibility knowledge

Education

Master degree in engineering/biochemistry/biology/medical

Job description

Materialise Belgium, part of Materialise Medical, seeks a highly qualified biocompatibility-focused engineer to drive validation and regulatory work for medical devices. You will work across cleaning, packaging, and sterilization processes, and support ISO 10993-1 assessments.

You will collaborate with Quality, Regulatory, Development, Process Engineering, and Manufacturing teams, build validation protocols, and contribute to regulatory submissions while staying compliant with work instructions.