Senior Biosafety Engineer

Intuitive Surgical seeks a Senior Biosafety Engineer to manage biological safety evaluations for surgical medical devices. The role involves collaborating with toxicologists, leading product development teams through compliance processes, and coordinating biocompatibility testing activities across multiple concurrent projects.

Responsibilities

• Collaborate with toxicologists to develop and implement biological safety assessment plans for new and existing products
• Serve as safety representative for product development teams; present at design reviews and manage stakeholder communication
• Monitor compliance with biocompatibility requirements; conduct assessments and implement necessary process changes
• Coordinate chemical characterization and biocompatibility testing with contract research organizations
• Create and maintain project tracking systems and documentation in the document management system

Requirements

• Bachelor's degree in medical life science or engineering; master's degree preferred
• 8+ years of experience in medical device product safety or product development
• Strong knowledge of ISO 10993 guidelines and biocompatibility standards
• Experience designing and implementing biocompatibility safety evaluations and risk assessments
• Understanding of global regulatory requirements and quality management systems
• Project management skills; PMP certification a plus
• In vitro and in vivo laboratory testing experience preferred