Biosafety Engineer — Medical Devices & Sterilization

Materialise; Heverlee; On-site; EUR 60,000 - 80,000; Full time

Job summary

Materialise Medical seeks a dedicated engineer to join the Medical Business Unit. You will contribute to biocompatibility evaluation, cleaning, packaging, and sterilization processes for medical devices, aligning with ISO 10993-1 and validation protocols.

The role requires a Master’s degree in a relevant field, strong regulatory awareness, and the ability to manage multiple projects while communicating clearly in English.

Qualifications

• Master's degree in engineering, biochemistry, biology, or medical field.
• Knowledge of regulatory requirements and ISO 10993-1 is preferred.
• Ability to manage multiple projects with strong planning and communication.
• Clear written and verbal communication in English.

Responsibilities

• Support biological safety evaluations according to ISO 10993-1.
• Execute cleaning, sterilization, and packaging validations.
• Develop new or optimized packaging for sterile and non-sterile devices.
• Coordinate tests with external labs and suppliers.
• Prepare validation protocols and reports compliant with work instructions.
• Contribute to regulatory submissions for new devices.

Skills

Biocompatibility evaluation

Cleaning validation

Packaging development

Sterilization validation

Regulatory submissions

Cross-functional collaboration

Education

Master's degree in engineering/biochemistry/biology/medical

Job description

Materialise Medical seeks a dedicated engineer to join the Medical Business Unit. You will contribute to biocompatibility evaluation, cleaning, packaging, and sterilization processes for medical devices, aligning with ISO 10993-1 and validation protocols.

The role requires a Master’s degree in a relevant field, strong regulatory awareness, and the ability to manage multiple projects while communicating clearly in English.