Validation Engineer, Sterility Assurance

Primary Function of 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. 

Essential Job Duties

• Manage routine Ethylene Oxide (EO) and radiation bioburden testing coordinate with cross-functional teams sterilizers and laboratories and drive projects to completion.
• Support Intuitives 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.

Qualifications :

Required Skills and Experience

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.

Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)

• Minimum Education: Bachelors of Science in Microbiology Engineering Life Science Chemistry or technical equivalent; Masters 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

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time