Sterility Assurance Validation Engineer — Safer Surgery

Socket.dev; Sunnyvale (CA); On-site; USD 120,000 - 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 daVinci instruments and accessories. You will interface with R&D, Manufacturing Engineering, Supplier Engineering, and Quality teams to drive projects to completion.

The role requires microbiology lab experience, knowledge of ISO 11135/11137, and strong communication skills. Travel to sites, including international travel, is expected.

Qualifications

• Bachelor’s degree in Microbiology, Engineering, Life Science, Chemistry or technical equivalent; Masters preferred.
• 4+ years of professional EO experience; radiation sterilization experience desired.
• Experience with EO and radiation sterilization testing and procedures.

Responsibilities

• Manage EO and radiation bioburden testing with cross-functional teams and drive projects to completion.
• Support internal microbiology lab and validated test methods.
• Apply technical expertise to bioburden programs, including trend analysis and investigations.
• Oversee multiple projects with internal and external partners (sterilizers, labs, suppliers).
• Provide technical support to sterilization release activities.
• Maintain bioburden procedures per recognized standards.
• Implement projects per approved budget and schedule.
• Review investigations and develop preventative actions related to sterilization nonconformities.
• Assist with external facility audits to support QMS.

Skills

Microbiology lab

ISO 11135/11137

Verbal & written comms

Leadership

Task prioritization

Risk management

Hands-on engineering

Attention to detail

MS Office

Travel to sites

Education

Bachelor’s in Microbiology, Engineering, Life Science, Chemistry

Job description

Intuitive Surgical in Sunnyvale, CA is seeking a Validation Engineer, Sterility Assurance to support sterilization processes for single-use daVinci instruments and accessories. You will interface with R&D, Manufacturing Engineering, Supplier Engineering, and Quality teams to drive projects to completion.

The role requires microbiology lab experience, knowledge of ISO 11135/11137, and strong communication skills. Travel to sites, including international travel, is expected.