Senior Biocompatibility Engineer
Core
Evaluating medical device products for biological safety and performing scientific risk assessments to support design control and regulatory submissions.
Role type
Senior Biocompatibility Engineer
Builds
Medical devices for cardiopulmonary and respiratory care (AEDs, ventilators, trauma kits)
Domain
Medical Devices / Biocompatibility / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biocompatibility risk assessment, ISO 10993/18562 standards, EU MDR regulations, material/chemical characterization, in vitro/in vivo study oversight, regulatory submission authoring, GLP compliance
Preferred skills
complex project initiation, analytical chemistry, polymer chemistry, medical device product development process
Technologies
ISO 10993, ISO 18562, EU MDR, FDA, APAC regulatory frameworks
Responsibilities
Perform biological risk assessments for manufacturing and material changes; develop biological evaluation plans; oversee in vitro and in vivo studies; author biocompatibility evaluation reports; support global regulatory submissions and audits; manage biocompatibility assessment documents
Seniority
Senior, hands-on IC
