Validation Engineer, Sterility Assurance (EO/Radiation)

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Validation Engineer, Sterility Assurance to support EO and radiation sterilization for single-use instruments and accessories.

You will interface with R&D, Manufacturing Engineering, Supplier Engineering, and Quality Engineering to drive sterilization testing and compliance. The role requires microbiology experience, knowledge of ISO 11135/11137, strong communication, leadership, and the ability to manage multiple projects in a fast-paced environment.

Qualifications

• Must have microbiology lab experience or good working knowledge of sterility assurance test requirements.
• Working knowledge of international medical device sterilization standards, such as ISO 11135 and ISO 11137.
• Excellent verbal and written communication, teamwork, and interpersonal skills to work across multiple constituents.
• Self-starter with ability to take leadership in a fast-paced environment.
• Able to prioritize and smoothly manage multiple tasks.
• Able to manage project risk and timely escape issues to senior management and team.
• Hands-on engineering skills with the proven ability to work well in a team environment and drive individual projects.
• Ability to focus, and attention to detail along with a strong track record of continuous improvement initiatives.
• Well versed in MS Office Suite.
• Ability to travel to supplier, sterilizer, or laboratory sites, including international travel.

Responsibilities

• Manage routine Ethylene Oxide (EO) and radiation bioburden testing, coordinate with cross-functional teams, sterilizers, and laboratories and drive projects to completion.
• Support Intuitive's internal microbiology lab, following validated test methods as required.
• Apply technical expertise to the bioburden program (e.g. interpretation of results, investigation of excursions, etc.).
• Support the bioburden program, involving rigorous data analysis with focus on the safety and efficacy of single-use daVinci® surgical instruments and accessories for new products and sustaining projects (e.g. cost reduction, process improvements, etc.).
• Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (sterilizers, suppliers, and laboratories).
• Provide technical support to routine sterilization release activities.
• Maintain Intuitive Surgical bioburden procedures based on recognized standards.
• Implement projects per approved budget and schedule.
• With support from the sterilization team, conduct, review and approve incident investigations. Review corrective actions and develop reliable preventative actions related to sterilization as a result of any nonconformity.
• Assist with compliance audits for external facilities as required to support quality management system.

Skills

Microbiology lab

Sterilization standards

Communication

Leadership

Project management

Engineering skills

Attention to detail

MS Office

Travel readiness

Education

Bachelor's degree in Microbiology, Engineering, Life Science, Chemistry or technical equivalent

Job description

Intuitive Surgical, Inc. is seeking a Validation Engineer, Sterility Assurance to support EO and radiation sterilization for single-use instruments and accessories.

You will interface with R&D, Manufacturing Engineering, Supplier Engineering, and Quality Engineering to drive sterilization testing and compliance. The role requires microbiology experience, knowledge of ISO 11135/11137, strong communication, leadership, and the ability to manage multiple projects in a fast-paced environment.