Senior Biocompatibility & Biosafety Engineer

Intuitive; Sunnyvale (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Intuitive Surgical, a leader in robotic surgery, seeks a Biosafety Development Engineer to manage and collaborate on the biological safety evaluation process for new products and changes. The role requires deep toxicology and analytical chemistry knowledge, plus experience in biocompatibility safety evaluations, risk assessments, and regulatory compliance.

You will work with toxicologists and engineers to implement safety plans, track compliance, and coordinate with CROs to support FDA filings

Qualifications

• Experience designing and implementing biocompatibility safety evaluations and risk assessments.
• Familiarity with in vitro/in vivo test methods and chemical analyses.
• Ability to plan, track, and implement biosafety evaluations for medical devices per ISO 10993.

Responsibilities

• Collaborate with toxicologists and specialists to support the biological safety program.
• Represent biological safety on new product development and design reviews; communicate schedules.
• Ensure processes align with biocompatibility requirements set by regulatory bodies; implement changes as needed.
• Coordinate testing activities with CROs; request quotes and track schedules.
• Create and maintain project management tools to track biosafety activities and progress.
• Maintain comprehensive tracking for all compliance projects and ensure accessible documentation.
• Engage with stakeholders to address requirements and inquiries; communicate clearly.
• Support regulatory filing activities including FDA 510(k) submissions and MDR compliance.

Skills

Toxicology

Analytical chemistry

Biocompatibility

Regulatory understanding

Project coordination

Tools

ISO 10993 standards

CRO coordination

Document management systems (Agile)

Job description

Intuitive Surgical, a leader in robotic surgery, seeks a Biosafety Development Engineer to manage and collaborate on the biological safety evaluation process for new products and changes. The role requires deep toxicology and analytical chemistry knowledge, plus experience in biocompatibility safety evaluations, risk assessments, and regulatory compliance.

You will work with toxicologists and engineers to implement safety plans, track compliance, and coordinate with CROs to support FDA filings