Biosafety Engineer

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

At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment — helping improve and save lives daily.ResponsibilitiesWithin 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 with work instructions and standards. You assess the impact of the process or product changes and propose adequate actions. You plan and follow up on 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.RequirementsMaster degree (engineering, biochemistry, biology, or medical)Knowledge and understanding of regulatory requirements, standards, and guidance documents in the field of biocompatibility evaluation, cleaning validation, packaging development, or sterilization validation of medical devices.Able to work on multiple projects simultaneously, set priorities, and establish short- and long-term planning horizons.Effective as a team member to accomplish project deadlines and objectives, yet able to work and make decisions independently to reach goals.Clear and effective verbal communication and technical writing skills in English.Good analytical skills, meticulous approach with a high level of attention to detail.Passionate about patient safety and customer satisfactionWhat’s waiting for youWork that mattersThe technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it. No matter your role, we unlock new possibilities to build a better and healthier world every day.At Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.A people-centered spaceWhen you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back.At the same time, we expect you to invest in the people around you — not just your own work — to make the group stronger than the sum of its parts.An environment of trustAs a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls.At Materialise, we expect you to deliver on that trust and keep your commitments.A career ready to buildWhen you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here.At Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.Make a difference together with the Medical team.