Senior Biosafety Engineer: Shape Safer Medical Devices

Socket.dev; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical is seeking a Biosafety Development Engineer to lead biological safety evaluation for new products and changes, partnering with toxicologists and engineering teams.

You will design and implement biocompatibility safety evaluations, risk assessments, and testing plans, ensuring compliance with global regulatory standards while maintaining thorough documentation and communication with stakeholders.

Qualifications

• Bachelor's degree in life sciences or engineering required; master's preferred.
• 8+ years of experience in medical device safety, development, or related areas.
• Experience with biocompatibility testing, ISO 10993, and regulatory filings preferred.
• Strong communication and project management skills.

Responsibilities

• Collaborate with toxicologists to support the biological safety program.
• Represent biosafety in new product development teams and design reviews.
• Ensure processes align with biocompatibility requirements; implement changes to achieve compliance.
• Coordinate with sustaining and supplier engineering to track design changes and safety plans.
• Regularly review and update biosafety processes based on new standards and regulations.
• Create and maintain project management tools to track activities and progress.
• Maintain a comprehensive tracking system for compliance projects and documentation.
• Engage stakeholders to address regulatory and compliance inquiries.

Skills

Biological safety

Toxicology knowledge

Regulatory compliance

Project management

Analytical chemistry

Education

Bachelor's degree in life sciences or engineering

Master's degree preferred

Tools

MS Office

Job description

Intuitive Surgical is seeking a Biosafety Development Engineer to lead biological safety evaluation for new products and changes, partnering with toxicologists and engineering teams.

You will design and implement biocompatibility safety evaluations, risk assessments, and testing plans, ensuring compliance with global regulatory standards while maintaining thorough documentation and communication with stakeholders.