Intuitive · 2 days ago
Manager, Systems Engineering
Sunnyvale, CA
Full-time
Onsite
Senior Level
$192K/yr - $277K/yr
7+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, committed to enhancing minimally invasive care. They are seeking a Systems Engineering Manager who will be responsible for ensuring the electrical safety and performance of advanced medical devices, while also communicating complex technical concepts to diverse audiences. This role requires a strong technical leader with expertise in medical device safety standards and a collaborative approach to cross-functional leadership.
Health CareManufacturingMedical Device
Responsibilities
Lead the definition and decomposition of detailed system requirements, ensuring traceability to user needs, product specifications, and global regulatory standards
Architect and optimize electrical systems, including power distribution, signal integrity, sensor interfaces, control systems, and user interface elements, in close collaboration with mechanical, software, and clinical engineering teams
Drive robust design decisions that balance performance, reliability, cost, manufacturability, and long-term serviceability
Articulate highly technical electrical and safety concepts clearly and concisely to non-technical audiences, including marketing, sales, clinical specialists, regulatory affairs, and senior management
Develop simplified explanations, diagrams, and presentations to convey complex electrical design rationale, safety measures, and compliance strategies
Represent the engineering team in cross-functional meetings, regulatory audits, and discussions with external partners, ensuring transparent and understandable communication
Prepare clear and compelling technical reports, white papers, and documentation that can be understood by various stakeholders
Act as the company's leading subject matter expert (SME) on IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) and its associated collateral standards (e.g., IEC 60601-1-2 for EMC, IEC 60601-1-6 for Usability, and other particular standards)
Proactively embed IEC 60601-1 compliance into electrical designs from the earliest concept stages through to final product verification
Define, oversee, and interpret results from electrical safety testing protocols (e.g., leakage current, dielectric strength, protective earthing, creepage and clearance distances, insulation coordination)
Collaborate with external test houses and Notified Bodies to facilitate smooth safety and EMC testing for global product certifications
Develop and maintain comprehensive documentation, including technical reports, compliance matrices, and risk management files (per ISO 14971) related to electrical safety
Act as a key technical leader, fostering strong collaboration across all engineering disciplines and functional groups (Quality, Regulatory, Manufacturing, Clinical)
Mentor and provide technical guidance to junior electrical and systems engineers, promoting best practices in design, safety, and documentation
Maintain up-to-date knowledge of evolving medical device regulations, industry standards (especially for electrical safety and EMC), and emerging systems engineering technologies
Proactively identify and champion opportunities for process improvement within the systems and hardware engineering functions
Qualification
Required
Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a closely related field
Minimum of 7+ years of progressive experience in electrical engineering within the medical device industry, with at least 3 years in a senior or lead systems engineering role
Demonstrated expert-level knowledge of IEC 60601-1 (including Amendment 2) and its relevant collateral standards (e.g., IEC 60601-1-2, -1-6, -1-8, -1-11)
Proven experience in applying ISO 14971 (Risk Management for Medical Devices) principles to hardware design and safety
Strong proficiency in analog and digital circuit design, power supply design (AC-DC, DC-DC), sensor integration, and signal conditioning for patient-facing applications
Hands-on experience with schematic capture and PCB layout tools (e.g., Altium Designer, OrCAD, Cadence)
Expertise with electrical test and measurement equipment (oscilloscopes, multimeters, power analyzers, hipot testers, leakage current testers, spectrum analyzers, etc.)
Excellent understanding of electromagnetic compatibility (EMC) design principles and experience with EMC testing for medical devices
Familiarity with medical device quality management systems (e.g., ISO 13485, FDA QSR)
Exceptional written and verbal communication skills, with a proven ability to distill complex technical information into clear, actionable insights for non-technical audiences. This includes strong presentation skills
Superior problem-solving, analytical, and critical thinking abilities
Preferred
Experience with high-voltage and high-power electrical systems in medical devices
Understanding of embedded systems and firmware development lifecycle (e.g., IEC 62304)
Experience in conducting or supporting root cause analysis (RCA) investigations related to electrical failures
Prior involvement in successful regulatory submissions (e.g., 510(k), CE Mark) and direct interaction with regulatory agencies
Benefits
Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Craig Child
Sr. Vice President, Human Resources
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Recent News
2025-12-11
2025-11-14
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