Scientist Biocompatibility
Core
Executes biological safety evaluations of medical device products and materials to ensure compliance with global standards and regulations.
Role type
Scientist Biocompatibility (R&D Product Development)
Builds
Medical device products meeting biological safety requirements
Domain
MedTech / Biomedical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biocompatibility evaluation, Toxicology assessment, GLP guidelines, ISO 10993 standards, In vitro and in vivo testing, Regulatory compliance, Risk assessment, Laboratory investigation design, Data interpretation, Documentation
Preferred skills
Biofabrication, Biomaterials, Biostatistics, Preclinical research, Manufacturing processes understanding, SAP Product Lifecycle Management
Technologies
SAP Product Lifecycle Management
Responsibilities
Evaluate medical device products and materials for biological safety per international regulations and GLP guidelines; Design, initiate, coordinate, and interpret laboratory investigations for biocompatibility and toxicology studies; Apply technical expertise to solve biocompatibility problems related to ISO 10993 standards; Liaise with cross-functional teams to review documentation and coordinate test strategies; Review, interpret, and summarize testing data for risk assessment reports; Support regulatory/notified body requests during audits and submissions; Identify and evaluate potential risks and drive resolution; Participate in continuous improvement activities and shape processes.
Seniority
Mid-level IC (2+ years experience) or Senior IC (PhD + 1 year experience)
