Validation Engineer, Sterility Assurance

Intuitive•Sunnyvale, CA

2d•Onsite

About The Position

Intuitive Surgical designs and manufactures highly complex systems for use in surgery. These systems employ a combination of reusable and single use surgical instruments and accessories for each surgical procedure. 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. Supporting this role will be a technical and management team that knows and cares about what you are doing and wants you to succeed.

Requirements

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 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, 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.

Nice To Haves

radiation sterilization experience is also desired.

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.