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Intuitive

Senior Project Electrical Engineer

Posted 5 Days Ago
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In-Office
Sunnyvale, CA
Senior level
In-Office
Sunnyvale, CA
Senior level
Lead requirements and regulatory documentation for an advanced energy medical device: own the DHF, author functional requirements, run DFMEAs and risk assessments, produce clinical/trial documentation, support board bring-up and electrical safety testing, and coordinate tasks across EE, ME, SW, clinical, and regulatory stakeholders.
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Company Description

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.

Were 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.

The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.

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
We are seeking a Senior Project Electrical Engineer for Intuitive’s advanced R&D group (Future Forward). This role is focused on developing and maintaining requirements documentation for a novel advanced energy platform. You will be a key technical documentation owner within a cross-functional team, working alongside electrical, mechanical, software, and clinical engineers under an aggressive development timeline.

This role is best suited for someone who thrives in ambiguity, embraces the organized chaos of early-stage R&D, and knows when to drive independently versus escalate to the system architect.

Design History File & Requirements Ownership

  • Own and maintain the Design History File (DHF) for an advanced energy delivery medical device throughout the development lifecycle. Ensure all system-level documentation complies with ISO 13485 and FDA 21 CFR 820.
  • Author detailed Functional Requirements Documents (FRDs), translating high-level system requirements from the project architect into testable, traceable specifications.
  • Negotiate requirements specifics with cross-functional stakeholders (EE, ME, SW, Clinical, Dosimetry) and manage tradeoffs with input from the system architect.
  • Understand the downstream impact of requirements decisions on safety, performance, manufacturability, and clinical outcomes.

Risk Management & DFMEA

  • Lead Risk Assessments and Design Failure Mode and Effects Analyses (DFMEAs) in accordance with applicable standards (ISO 14971, IEC 60601 series, etc.).
  • Work collaboratively with the system architect and cross-functional team to identify, evaluate, and mitigate design risks.

Technical & Clinical Documentation

  • Write and compile technical documentation for clinical use, including:
    • Instructions for Use (IFUs)
    • Troubleshooting guides for clinical trial sites
    • Clinical trial device documentation packages
  • Coordinate with the project architect and clinical team to ensure accuracy, completeness, and regulatory alignment.

Hands-On Engineering Support

  • Support board bring-up activities as needed, including bench-level debugging of high-voltage electronics.
  • Assist with electrical safety compliance testing: leakage current, dielectric testing, and related IEC 60601 evaluations.
  • Track tasks, milestones, and open issues using project management tools; maintain visibility for the team and leadership.

Qualifications

Required Qualifications

Technical

  • BS, MS, or PhD in Electrical Engineering, Physics, or a closely related discipline.
  • Experience: Typically requires a minimum of 8 years of related experience with a University degree; or 6 years’ experience and a Master’s degree; or a PhD with 3 years’ experience; or equivalent experience.
  • Strong fundamentals in electrical engineering, with emphasis on power electronics and RF electronics.
  • Solid working knowledge of medical device documentation practices (DHF, requirements, risk management).
  • Working knowledge of medical device electrical safety standards, particularly IEC 60601-1 and its collateral/particular standards.
  • Familiarity with ISO 14971 (risk management for medical devices).
  • Comfortable with basic laboratory tools: oscilloscope, soldering iron, bench power supplies, DMMs.
  • Proficiency in Python scripting for data analysis or test automation.

Tools & Process Experience

  • Experience with project management tools: Jira, Smartsheet, or equivalent.
  • Experience with requirements management software: Jama, DOORS, Polarion, or equivalent.

Soft Skills & Mindset

  • Detail-oriented with strong documentation discipline.
  • Comfortable navigating the ambiguity and rapid pace of early-stage R&D.
  • Able to dynamically problem-solve and exercise judgment about when to escalate issues to the system architect versus resolving them independently.
  • Strong written and verbal communication skills; ability to interface across engineering, clinical, and regulatory disciplines.
  • Effective logistics coordination skills across a multidisciplinary team.

Preferred Qualifications

  • Experience with surgical advanced energy modalities: RF ablation, Microwave, Pulsed Electric Field (PEF), Cryotherapy, Ultrasound, or similar.
  • Prior experience contributing to a Design History File for an FDA-regulated device (510(k), PMA, or IDE/clinical trial pathway).
  • Exposure to first-in-human (FIH) or clinical trial device development.

Additional Information

Working Conditions

  • International Travel required (5-10%)

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.

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