Senior Project Electrical Engineer

Requirements

• 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.
• 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.

Additional Information

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. 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.

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Company Intel

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