Validation Engineer, Sterility Assurance

Socket.dev; Sunnyvale (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking a Validation Engineer, Sterility Assurance to support sterilization processes for single-use daVinci instruments and accessories. You will interface with R&D, Manufacturing Engineering, Supplier Engineering, and Quality teams to drive projects to completion.

The role requires microbiology lab experience, knowledge of ISO 11135/11137, and strong communication skills. Travel to sites, including international travel, is expected.

Qualifications

• Bachelor’s degree in Microbiology, Engineering, Life Science, Chemistry or technical equivalent; Masters preferred.
• 4+ years of professional EO experience; radiation sterilization experience desired.
• Experience with EO and radiation sterilization testing and procedures.

Responsibilities

• Manage EO and radiation bioburden testing with cross-functional teams and drive projects to completion.
• Support internal microbiology lab and validated test methods.
• Apply technical expertise to bioburden programs, including trend analysis and investigations.
• Oversee multiple projects with internal and external partners (sterilizers, labs, suppliers).
• Provide technical support to sterilization release activities.
• Maintain bioburden procedures per recognized standards.
• Implement projects per approved budget and schedule.
• Review investigations and develop preventative actions related to sterilization nonconformities.
• Assist with external facility audits to support QMS.

Skills

Microbiology lab

ISO 11135/11137

Verbal & written comms

Leadership

Task prioritization

Risk management

Hands-on engineering

Attention to detail

MS Office

Travel to sites

Education

Bachelor’s in Microbiology, Engineering, Life Science, Chemistry

Job description

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 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.

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 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.

Required Education and Training

• 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

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 employees who 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 government’s 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 employee’s start 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 dependingbusiness need and/or on the selected candidate’s experience, knowledge and skills.Compensation will be based primarily on the job level at which the role is filled and thecandidate’s 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.

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.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.