Senior Biocompatibility & Biosafety Engineer

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical is seeking a Biosafety Development Engineer to lead biological safety evaluations for new products and changes, ensuring compliance with regulatory standards and internal procedures. You will collaborate with toxicologists, engineers, and suppliers to drive safety assessments and documentation.

The role requires coordinating tests, maintaining tracking systems, and contributing to FDA submissions and other regulatory activities while staying current with evolving biosafety

Qualifications

• Strong understanding of toxicology and analytical chemistry for biological safety of medical devices.
• Experience designing and implementing biocompatibility safety evaluations and risk assessments.
• Familiarity with ISO 10993 guidelines and regulatory requirements for biosafety.

Responsibilities

• Collaborate with toxicologists and biosafety specialists to implement safety programs.
• Represent biological safety in product development meetings and design reviews.
• Monitor compliance with biocompatibility requirements and update procedures as standards evolve.
• Coordinate testing activities with CRO laboratories and manage project documentation.

Skills

Toxicology

Analytical chemistry

Biocompatibility testing

ISO 10993

Regulatory compliance

Project management

Documentation

Tools

Agile

Job description

Intuitive Surgical is seeking a Biosafety Development Engineer to lead biological safety evaluations for new products and changes, ensuring compliance with regulatory standards and internal procedures. You will collaborate with toxicologists, engineers, and suppliers to drive safety assessments and documentation.

The role requires coordinating tests, maintaining tracking systems, and contributing to FDA submissions and other regulatory activities while staying current with evolving biosafety