Clinical Development Engineering, Operations Lead

Posted 16 Days Ago
Be an Early Applicant
Sunnyvale, CA, USA
Hybrid
Senior level
Healthtech • Robotics
The future of Intuitive is bright—and it will take curious, driven, and diverse team members to get us there.
The Role
Lead pre-clinical lab operations for the CDE Ion platform: plan staffing and capacity, manage inventory and vendors, ensure IACUC and regulatory compliance, build training/onboarding, develop SOPs and metrics, coordinate cross-functional execution of pre-clinical studies, and drive continuous improvement.
Summary Generated by Built In
Company Description

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.

Job Description

Primary Function of Position
CDE Operations (CDE Ops) Lead position reports to the Sr. Manager/Director of Clinical Development Engineering on the Ion Endoluminal platform. In this position, CDE Ops collaborates with Engineering, Comparative Medicine, clinical technicians and external suppliers to support the CDE team from ideation through delivery of new product solutions. Their primary focus is to deliver business results through effective management of pre-clinical lab operations, driving efficiency through program planning, inventory management, communications and team training.  CDE Ops is expected to contribute across the full range of the CDE program, including daily operations and long-range planning, educational offerings and recruiting/training of staff.

Essential Job Duties 

  • Own integrated planning across staffing, lab capacity, specimen demand and forecasting for the CDE program
  • Leverage expertise to define, track, and drive key lab utilization metrics and dashboards
  • Develop and monitor lab forecasts to inform program budgeting and identify potential operational constraints
  • Build and scale training and onboarding programs for lab technicians and CDE team members, including tools and competency tracking
  • Manage capital equipment, lab inventory, service contracts, and third-party vendors to ensure operational readiness and cost efficiency
  • Ensure compliance with IACUC and all applicable regulatory and institutional lab standards
  • Develop and implement SOPs and workflows to improve efficiency, quality, and scalability of lab operations
  • Lead cross-functional planning and execution across Comparative Medicine, CDE, and Test Engineering teams
  • Oversee end-to-end logistics for pre-clinical studies, physician engagements, and CDE events
  • Develop evaluation frameworks and metrics to assess program performance and drive continuous improvement
  • Identify operational risks and implement mitigation and contingency strategies
  • Support and operationalize pre-clinical model development activities (adjust based on intent)
  • Keep the organization’s vision and values at the forefront of decision making and action and consistently demonstrate those values internally and externally

 

Qualifications

Required Skills and Experience 

  • Ability to understand complex products
  • Ability to work on pre-clinical models
  • Experience in project coordination and managing multiple high priority projects
  • Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines to ensure project success
  • Strong interpersonal skills: able to use tact and diplomacy to maintain effective working relationships, able to raise problems or challenges in a productive manner
  • Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction. Creative in succeeding and applying simple solutions.
  • Strong project management, planning, decision making, negotiating and change management skills
  • Self-starter needing minimal supervision
  • Self-assured and able to react quickly under pressure
  • Excellent verbal and written communications skills required including presentation of technical content

Required Education and Training 

  • Minimum B.S. in technical or medical fields with project management as a bonus
  • Minimum of 6 years of industry experience with 2 years of relevant experience in people or program management

 

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 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.

Skills Required

  • Understand complex medical device products
  • Work with pre-clinical models
  • Project coordination and management of multiple high-priority projects
  • Experience working cross-functionally with engineering, comparative medicine, and test teams
  • Strong interpersonal, tact, and diplomacy skills
  • Proven ability to recognize critical issues and drive them to closure under pressure
  • Project management, planning, decision making, negotiating and change management skills
  • Self-starter who needs minimal supervision
  • Ability to perform under pressure and make rapid decisions
  • Excellent verbal and written communication, including technical presentations
  • Ensure compliance with IACUC and applicable regulatory/institutional lab standards
  • Minimum B.S. in technical or medical field
  • Minimum 6 years industry experience with at least 2 years people or program management experience
  • Project management education/training (bonus)

Intuitive Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Intuitive and has not been reviewed or approved by Intuitive.

  • Healthcare Strength Healthcare coverage appears broad and modern, including medical/dental/vision, telehealth, second-opinion services, fertility support, and condition-specific programs. Mental health support is positioned as strong, including access to free counseling sessions and a dedicated counseling service.
  • Wellbeing & Lifestyle Benefits Wellbeing and lifestyle offerings extend beyond core insurance, with initiatives such as vaccination clinics, fitness memberships, stress-reduction programs, and employee assistance programs. Additional lifestyle perks include curated discounts, pet insurance, identity theft prevention, and paid volunteer time.
  • Flexible Benefits Flexibility is supported through flexible work schedules and telecommuting options that can help with work-life integration. Benefit availability is described as variable by country, campus, and role, implying a menu that changes by eligibility and location.

Intuitive Insights

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The Company
HQ: Sunnyvale, CA
12,000 Employees
Year Founded: 1995

What We Do

Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to its offerings, and develops, manufactures, and markets the da Vinci surgical system and the Ion endoluminal system.

Why Work With Us

We bring together the thinkers and doers; those who pursue excellence and are energized by discovering ways to do what can’t yet be done. We question, we test, we challenge each other and the status quo until we see the impact we’ve made, until we’ve set a new standard for minimally invasive care. We revel momentarily in our achievements before sta

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