Senior Biosafety Engineer
Core
Manage and implement biological safety evaluation programs for robotic surgical devices, ensuring compliance with international standards and regulatory requirements for patient-contact materials.
Role type
Senior IC biosafety engineer (medical devices)
Builds
Robotic surgical platforms and associated patient-contact medical devices
Domain
Medical device industry + biocompatibility and toxicology
Required skills
biocompatibility safety evaluations, risk assessments, root-cause analysis, in vitro and in vivo test methods, chemical analyses, ISO 10993 guidelines, global regulatory compliance, quality management systems, FDA 510(k) submissions, MDR compliance certification
Preferred skills
PMP certification, project management, medical device biocompatibility testing training
Technologies
Agile (document management system), MS Office
Responsibilities
Collaborate with toxicologists to develop safety assessment plans; serve as biological safety representative for new product development; monitor processes for biocompatibility compliance; coordinate chemical characterization and biocompatibility testing at CRO laboratories; support regulatory filing activities; maintain biological safety material databases and tracking systems; assist engineering teams in selecting patient-contact materials.
Seniority
Senior, hands-on IC (via careerplan.io/jobs/744000153605567-senior-biosafety-engineer-at-intuitive)