Mgr Clinical Data

Intuitive Surgical Inc

Sunnyvale, CA

JOB DETAILS
SKILLS
Artificial Intelligence (AI), Biomedical Engineering, Cancer, Clinical Data Management, Clinical Practices/Protocols, Code of Federal Regulations, Communication Skills, Computer Science, Cross-Functional, Data Processing, Data Quality, Data Sets, Detail Oriented, Documentation, FDA (Food and Drug Administration), Government, Healthcare, ISO (International Organization for Standardization), Import/Export, Leadership, Licensing, Machine Learning, Machine Tool, Medical Diagnosis, Medical Equipment, Medical Imaging, Onboarding, Operational Improvement, Operations Processes, Organizational Skills, People Management, Performance Management, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Project/Program Management, Quality Control, Quality Management, Radiography, Regulations, Research & Development (R&D), Software Engineering, Standard Operating Procedures (SOP), Support Documentation, TCP (Transmission Control Protocol), Team Lead/Manager, Traceability, Training Data Sets, Training/Teaching, Ultrasound, Vendor/Supplier Management, Writing Skills
LOCATION
Sunnyvale, CA
POSTED
4 days ago

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.

Primary Function of Position

The Ion endoluminal system is Intuitive''s robotic platform for minimally invasive biopsy in the

peripheral lung, designed to improve the early diagnosis of lung cancer. The Ion R&D team is

looking for an experienced leader to own medical image dataset development. You will build and

scale a high-performing organization of internal annotation specialists and external partners,

delivering high-quality datasets to enable intelligent capabilities in our robotic platform.

In this role, you will work at the intersection of Machine Learning, Clinical and Regulatory Affairs,

and Data Operations. You will define organization-wide standards for dataset quality, establish

scalable data workflows, and serve as the single accountable owner for dataset readiness across

programs. You will directly accelerate the development of AI-powered technologies that help

physicians diagnose patients earlier and more accurately.

Essential Job Duties

Define and oversee dataset strategy and execution across multiple programs, balancing

competing priorities and timelines

Translate ML engineering and clinical requirements into clear dataset specifications

Manage multiple teams of internal labeling technicians, including hiring, onboarding,

training, performance management, and day-to-day workload planning

Procure and manage external annotation vendors and contractors to meet quality and

schedule targets

Track dataset progress and communicate status, risks, and tradeoffs to leadership

Partner with Regulatory Affairs and Clinical Affairs to ensure datasets meet FDA and

international guidelines

Establish and oversee quality control workflows, acceptance criteria, and rework

processes for data annotation

Define and enforce labeling guidelines, SOP's, and reviewer instructions in collaboration

with ML engineers and clinical SME's

Own the creation and maintenance of dataset documentation to support releases and

submissions

Improve data operations workflows, standards, and tooling across teams in partnership

with software and data engineering groups

Serve as the single accountable owner for dataset readiness

Required Skills and Experience

To qualify for this position, you must have:

A bachelor's degree in computer science, biomedical engineering, or equivalent

experience

Five or more years of experience in data operations or ML dataset management,

including experience leading multiple teams or programs

Experience working with medical imaging data (e.g., CT, X-ray, ultrasound)

Demonstrated experience managing people and/or external vendors in an operational or

technical environment

Strong project management skills with experience coordinating cross-functional work

Solid understanding of data quality, documentation, and traceability principles

Ability to interpret technical requirements and collaborate effectively with ML engineers

and clinical experts

Strong written and verbal communication skills

High levels of ownership, organization, and attention to detail

Preferred Skills and Experience

Ideally, a candidate would also have:

Experience working in an FDA-regulated medical device environment (e.g., 510(k), PMA,

MDR, ISO 13485)

Experience writing operating procedures, work instructions, or other quality system

documentation

Familiarity with annotation tools such as SuperAnnotate, Labelbox, CVAT, or similar

Understanding of AI/ML regulatory guidance (e.g., FDA Good Machine Learning Practice)

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 depending on

business 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 the

candidate'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.

About the Company

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Intuitive Surgical Inc