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.