Biocompatibility Engineer

Opportunity for a skilled professional to join a growing technical team and play a key role in ensuring the biological safety of innovative medical devices. This is a new position created as part of ongoing expansion.

As a Biocompatibility Engineer, you will be responsible for assessing and managing biological risks associated with materials and products, ensuring compliance with global regulatory standards. You will work closely with cross-functional teams to support material selection, develop testing strategies, and maintain technical documentation.

Key Responsibilities:

Conduct biological risk assessments for both new product development and existing products.

Develop and implement biocompatibility test plans and protocols in line with international standards.

Coordinate testing with external laboratories and suppliers.

Perform material characterization and maintain databases of safety and toxicological data.

Prepare and review technical documentation, including evaluation plans, reports, and literature reviews.

Ensure compliance with relevant regulatory requirements, including ISO 10993.

Review and approve biocompatibility test results and maintain best-practice templates and processes.

Support change management processes and contribute to technical documentation for engineering changes.

Communicate technical information clearly and effectively to internal and external stakeholders.

Drive continuous improvement initiatives within your area of responsibility.

Experience/Skills:

Degree (or higher) in a relevant discipline such as Biomedical Engineering, Materials Science, Chemistry, Biochemistry, or similar.

Experience working with ISO 10993 standards.

Background in a regulated industry (medical devices, pharmaceuticals, etc.).

Strong analytical and report-writing skills.

Excellent organizational skills and attention to detail.

This is a newly created role offering the chance to make a real impact in a growing organization. You’ll work on cutting-edge medical technologies in a collaborative environment that values innovation and professional development