Senior Project Electrical Engineer

Primary Function of Position
We are seeking a Senior Project Electrical Engineer for Intuitives 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 Masters 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 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