Validation Engineer, Sterility Assurance

About the Company

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

About the Role

The primary function of the Validation Engineer, Sterility Assurance is to support sterilization processes of existing and newly developed single-use products. This person will act as an interface between internal project teams (e.g., Research and Development, Manufacturing Engineering, Supplier Engineering, Quality Engineering, etc.) and external laboratories and sterilizers. The successful candidate must excel in a high-energy, high-transaction, small and focused team environment, be able to drive to solutions from rough requirements, and have a commitment to high product quality and compliance. The ability to understand project goals and communicate test plans required to achieve those goals is essential. A strong sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting.

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 the quality management system.

Requirements

• 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 the ability to take leadership in a fast-paced environment.
• Able to prioritize and smoothly manage multiple tasks.
• Able to manage project risk and timely escalate 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, attention to detail, and 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.

Qualifications

• Minimum Education: Bachelor of Science in Microbiology, Engineering, Life Science, Chemistry, or technical equivalent; Master’s is preferred.
• Minimum of 4 years of professional experience with Ethylene Oxide; radiation sterilization experience is also desired.

Working Conditions

• Ability to work hands-on in a laboratory environment.

Pay

Base Salary Range Region 1: $123,000 - $177,000

Base Salary Range Region 2: $104,600 - $150,500

Schedule

• Shift: Day

Workplace Type

Onsite - This job is fully onsite.