Senior Biosafety Engineer — Medical Devices

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 163,000 - 234,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Biosafety Development Engineer to manage biological safety evaluations for new and existing medical devices.

You will work with toxicologists to develop safety assessment plans, ensure compliance with biosafety standards, and coordinate testing with CRO laboratories. A strong background in toxicology and analytical chemistry, plus experience with ISO 10993, is required.

Qualifications

• Minimum bachelor's degree in medical life science or engineering; master's degree preferred.
• 8+ years of experience in medical device product safety, product development, or related areas.

Responsibilities

• Support biological safety program alongside toxicologists and specialists.
• Represent biosafety in new product development teams and design reviews.
• Monitor compliance with biocompatibility requirements and regulatory standards.
• Coordinate testing with CRO laboratories and track schedules.
• Develop and maintain project management tools for biosafety activities.

Skills

Biological safety

Toxicology

Regulatory knowledge

Project management

Education

Bachelor's degree in medical life science or engineering

Master's degree preferred

Job description

Intuitive Surgical, Inc. is seeking a Biosafety Development Engineer to manage biological safety evaluations for new and existing medical devices.

You will work with toxicologists to develop safety assessment plans, ensure compliance with biosafety standards, and coordinate testing with CRO laboratories. A strong background in toxicology and analytical chemistry, plus experience with ISO 10993, is required.