Biosafety Engineer

ENGINEERING

HYBRID

Are you interested in additive manufacturing activities in a medical environment? Are you passionate about patient safety? Would you love to work at the crossroads between engineering and biology? Then it's you we are looking for to complete our team as a Biosafety Engineer.

• Within the Medical Business Unit, you are part of the team of specialists that ensure the biocompatibility of our medical devices and that develop and validate their cleaning, packaging and sterilization processes.
• You participate in medical device development by supporting biological safety evaluations in accordance with ISO 10993-1 and by executing cleaning and sterilization process validations. In addition, you develop new or optimized packaging for sterile and non-sterile medical devices and test their performance. You set up and take part in monitoring programs to ensure continued fulfillment of requirements. You contribute to regulatory submissions of new devices.
• You build a thorough understanding of the manufacturing process, especially the steps related to cleaning, packaging, and sterilization, to effectively plan new development and validation activities. You create and finalize validation protocols and reports ensuring they are clear, concise and compliant to work instructions and standards. You assess the impact of the process or product changes and propose adequate actions. You plan and follow-up test sample production with the manufacturing team and with suppliers. You coordinate the tests that are being performed at external test labs.
• You interact closely with internal stakeholders (including the Quality, Regulatory, Development, Process Engineering, and Manufacturing teams) and external partners (including test labs and suppliers) to ensure good communication and swift collaboration.
• You act as an ambassador and safeguard of biological safety within Materialise Medical.

• Master's degree in engineering, biochemistry, biology, or a related medical field.
• 3–6 years of hands-on experience in biosafety within the medical device industry, with a strong understanding of biocompatibility evaluation, cleaning validation, packaging development, and/or sterilization validation.
• Deep knowledge of regulatory requirements, standards, and guidance documents related to medical device biosafety.
• Proven ability to manage multiple projects and drive initiatives from concept to implementation, ensuring compliance with global regulations.
• Experience in cross-functional collaboration, supporting R&D, quality, and regulatory teams to ensure biosafety compliance and best practices.
• Strong problem-solving and decision-making skills, with the ability to work independently while aligning with business and regulatory objectives.
• Excellent communication skills, including the ability to present findings, write technical reports, and provide expert guidance on biosafety topics in English.
• Analytical and detail-oriented mindset, with a proactive approach to identifying risks and implementing improvements.
• Passionate about patient safety and continuous improvement, with a commitment to maintaining high biosafety and quality standards.

• Full-time
• Hybrid

Curious to learn more about this position? Reach out to our team to get the answers to your questions.