Are you a detail‑driven Biocompatibility Engineer looking to take the next step in your career with a leading innovator in the medical device sector? We’re partnering with a well‑established, globally recognised manufacturer who is expanding its Sustained Engineering function and seeking a specialist to strengthen its biological safety capabilities.
This is a fantastic opportunity to join a highly skilled technical team working on life‑enhancing medical technologies. You’ll play a key role in ensuring products meet the highest standards of biological safety, supporting both new product development and remediation of existing products.
As a Biocompatibility Engineer, you will be responsible for planning, executing, and documenting biocompatibility assessments in line with international regulatory standards (including ISO 10993). You’ll collaborate closely with cross‑functional teams, external laboratories, and suppliers to ensure materials and devices are safe, compliant, and aligned with current best practices.
Your responsibilities will include:
- Conducting biological risk assessments and device characterisation for both new and existing products
- Developing test strategies, protocols, and coordinating external testing
- Performing material characterisation and maintaining MSDS/toxicological databases
- Producing and reviewing key documentation such as Biocompatibility Evaluation Plans/Reports and literature reviews
- Ensuring compliance with global regulatory requirements and biological safety standards
- Reviewing and approving biocompatibility test results
- Supporting change management processes and contributing to technical documentation
- Communicating technical information clearly and effectively
- Managing your workload proactively and contributing to continuous improvement initiatives
We’re looking for someone who thrives in a regulated, fast‑paced environment and takes pride in delivering high‑quality technical work.
Essential Qualifications & Experience:
- Degree or Master's in Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, or similar
- Experience working to ISO 10993
- Background in a regulated industry (Medical Devices, Pharma, etc.)
- Strong analytical, reporting, and documentation skills
- Excellent communication skills and attention to detail
Desirable Experience:
- Knowledge of MDD/MDR requirements
- Experience in ISO 13485 environments
- Familiarity with FDA guidelines and ISO 14971
- Experience with PLM systems (e.g., Windchill)
Personal Attributes:
- Highly organised, proactive, and able to prioritise effectively
- A natural completer‑finisher with strong problem‑solving skills
- Resilient, enthusiastic, and able to work independently
- Comfortable interacting with stakeholders at all levels
This is a rare opportunity to join a respected medical device manufacturer where your work directly contributes to patient safety and product excellence. You’ll be part of a supportive technical team, working on meaningful projects with real‑world impact.
If you’re passionate about biological safety and want to grow your career within a forward‑thinking organisation, we’d love to hear from you.