Sterility Assurance Validation Specialist

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

Job summary

Intuitive Surgical is seeking a Validation Engineer, Sterility Assurance to oversee EO and radiation bioburden programs for single-use devices and accessories. You will interface with R&D, Manufacturing, Quality, and external labs to drive projects to completion and improve processes while meeting regulatory requirements.

The role emphasizes data-driven decision making, strict adherence to validated methods, and collaboration across multiple teams to ensure the safety and efficacy of new and

Qualifications

• Experience managing EO and radiation bioburden testing.
• Ability to coordinate with cross-functional teams and external labs.
• Strong data analysis to ensure safety and efficacy of instruments.
• Familiarity with regulatory quality systems and sterilization standards.

Responsibilities

• Manage routine EO and radiation bioburden testing and coordinate with cross-functional teams, sterilizers, and laboratories to drive projects to completion.
• Support Intuitive’s internal microbiology lab, following validated test methods as required.
• Provide technical support to sterilization release activities.
• Maintain bioburden procedures based on recognized standards.
• Assist with compliance audits for external facilities as required to support quality management system.

Job description

Intuitive Surgical is seeking a Validation Engineer, Sterility Assurance to oversee EO and radiation bioburden programs for single-use devices and accessories. You will interface with R&D, Manufacturing, Quality, and external labs to drive projects to completion and improve processes while meeting regulatory requirements.

The role emphasizes data-driven decision making, strict adherence to validated methods, and collaboration across multiple teams to ensure the safety and efficacy of new and