Sterility Assurance Validation Engineer (Healthcare Tech)

Regulatory Jobs; Sunnyvale (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking a Validation Engineer, Sterility Assurance to support sterilization processes for single-use products and interface with internal and external labs.

You will manage EO and radiation bioburden testing, apply microbiology expertise, and drive projects to timely completion while upholding quality and regulatory standards. Strong collaboration and communication are essential in this high-energy team.

Qualifications

• Must have microbiology lab experience.
• Knowledge of ISO 11135 and ISO 11137 sterilization standards.
• Ability to work across multiple teams and communicate test plans.
• Experience with EO and radiation sterilization preferred.
• Strong data analysis and problem solving in bioburden programs.

Responsibilities

• Manage routine Ethylene Oxide and radiation bioburden testing with cross-functional teams.
• Support internal microbiology lab using validated test methods.
• Apply technical expertise to the bioburden program and investigations.
• Oversee multiple projects with internal departments and external labs.
• Provide technical support to sterilization release activities.
• Maintain bioburden procedures based on recognized standards.
• Implement projects per approved budget and schedule.
• Review investigations and develop preventative actions related to sterilization.
• Assist with external facility audits to support quality management.

Skills

Bioburden testing

Microbiology lab

Sterility standards ISO11135/11137

Cross-functional collaboration

Project leadership

MS Office Suite

Education

Bachelor's degree in Microbiology

Bachelor's degree in Engineering or Life Science

Bachelor's degree in Chemistry or technical equivalent

Masters preferred

Tools

MS Office Suite

Job description

Intuitive Surgical in Sunnyvale, CA is seeking a Validation Engineer, Sterility Assurance to support sterilization processes for single-use products and interface with internal and external labs.

You will manage EO and radiation bioburden testing, apply microbiology expertise, and drive projects to timely completion while upholding quality and regulatory standards. Strong collaboration and communication are essential in this high-energy team.