Are you someone who enjoys digging into the detail and making sure products are not just compliant, but genuinely safe for patients? If you have a strong background in biocompatibility and enjoy working in a fast-paced, regulated environment, this could be a great next step for you.
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
Were looking for a Biocompatibility Engineer to join our Sustained Engineering team.
In this role, youll play a vital part in ensuring medical devices and materials are biologically safe throughout their lifecycle from new product development through to products already on the market.
What youll be doing In this role, youll take ownership of biological safety activities and work closely with internal teams, suppliers, and external laboratories.
Your responsibilities will include: Performing biological risk assessments and characterisation for medical devices (NPD and in-market remediation) Developing biocompatibility strategies, test plans, and protocols in line with ISO 10993 Coordinating and managing biocompatibility testing with external labs and suppliers Carrying out material characterisation and maintaining databases of MSDS and toxicological data Producing clear, high-quality documentation such as Biocompatibility Evaluation Plans and Reports Reviewing and approving biocompatibility test results Ensuring ongoing compliance with global regulatory requirements and standards Supporting change management activities (ECOs) with biocompatibility input Responding to customer and stakeholder technical queries Contributing to continuous improvement across processes and ways of working Managing your workload proactively while supporting colleagues where needed What were looking for Essential Degree (or Masters) in Biochemistry, Chemistry, Chemical Engineering, (Bio)Medical Engineering, Materials Science, or a related discipline Experience working to ISO 10993 standards Experience in a regulated industry xkybehq (medical devices, pharma, or similar) Strong report writing and data analysis skills Excellent attention to detail and organisational skills Clear and confident written and verbal communication A proactive approach to problem-solving and workload management Desirable Knowledge of MDD (93/42/EEC) and MDR (2017/745) Experience working within an ISO 13485 quality system Familiarity with FDA guidelines and requirements Experience with ISO 14971 risk management Experience using a Product Lifecycle Management (PLM) system (e.g.
Windchill) Confidence working with stakeholders at different levels