Biosafety Engineer

AMjobcenter; Heverlee; On-site; EUR 70,000 - 90,000; Full time

Job summary

Materialise Medical is seeking a professional to support biocompatibility evaluations and validate cleaning, packaging, and sterilization processes for medical devices. You will coordinate with testing labs, manage sample production with manufacturing and suppliers, and contribute to regulatory submissions.

Join a team focused on patient safety and regulatory excellence, acting as a safety ambassador and collaborating across Quality, Regulatory, Development, and Manufacturing to ensure compliant

Qualifications

• Master degree in engineering, biochemistry, biology or medical field.
• Strong understanding of regulatory requirements in biocompatibility evaluation, cleaning validation, packaging development or sterilization validation.
• Ability to work on multiple projects simultaneously and set priorities.
• Independent decision-making with team collaboration.
• Clear and effective verbal communication and technical writing in English.
• Strong analytical skills and meticulous attention to detail.

Responsibilities

• Support biocompatibility evaluations in accordance with ISO 10993-1.
• Develop and validate cleaning, packaging, and sterilization processes.
• Contribute to validation protocols and reports; ensure clarity and compliance.
• Coordinate tests with external labs and manage sample production with manufacturing and suppliers.
• Interact with internal stakeholders and external partners to ensure smooth collaboration.
• Act as ambassador for biological safety within Materialise Medical and safeguard safety measures.

Education

Master 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.

Responsibilities

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 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.

Requirements

• Master 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 satisfaction

What’s waiting for you

Work that matters

The 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 space

When 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 trust

As 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 build

When 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.