Intuitive · 1 day ago
Hardware Compliance Engineer
Sunnyvale, CA
Full-time
Onsite
Senior Level
$168K/yr - $242K/yr
6+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Hardware Compliance Engineer will be responsible for EMC/wireless verification and Safety test support for new and current product platforms, leading interactions with outside labs and ensuring compliance with safety standards.
Health CareManufacturingMedical Device
Responsibilities
Responsible for driving EMC/wireless compliance and supporting projects in design for non-FDA regulatory compliance (Safety and EMC/wireless) with multi-disciplinary project teams
Drive Regulatory verification activities (Safety and EMC/wireless) for new products and sustaining activities of current platforms
Define and develop test plans, conduct compliance testing, and lead efforts to solve mechanical, EMI and safety problems
Partner with product development teams and NRTLs (Nationally Recognized Test Labs) in achieving product certification and regulatory approvals including scheduling test labs, reviewing product readiness, setting up products at test labs and verifying EMC and wireless test done correctly by test labs
Provide technical support for UL Follow-Up Service (FUS) quarterly inspections
Maintain accurate documentation of all actions required to achieve product certifications and to resolve issues, following up with engineering and manufacturing as needed
Create documentation to include design validation, risk analysis, and design review
Maintain current knowledge of EMC/wireless and Safety medical standards and testing procedures
Make recommendations for process improvements in escalation of technical support cases to engineering and manufacturing
Provide safety and EMC/wireless input to product development/design activities for new products or upgrades to existing products within defined development procedures
Lead Global EMC and wireless certification activities for Intuitive products with wireless components (e.g. WLAN, Bluetooth, etc.)
Prepare, review and submit technical documentation to regulatory agencies and certified bodies focused on EMC and wireless requirements (e.g. FCC, ISED, CE RED, MIC, KC, SRRC, ANATEL, IFETEL, NCC, RCM, IMDA, ICASA, etc.)
Manage EMC and wireless certification records related to EMC and wireless approvals for all applicable product lines
Communicate with regulatory agencies and certified bodies during EMC and wireless certification post market surveillances/audits
Identify country-specific EMC and wireless compliance and related EMC and wireless labeling needs to support product introduction in new market/region
Educate internal teams on EMC and wireless certification requirements and best practices
Qualification
Required
Associates Degree required with Bachelors Degree preferred in electronic, mechanical, or biomedical engineering, or equivalent
Demonstrated knowledge of Requirements Standards EN60601-1 and EN60601-1-2 for Medical Equipment Safety and EMC/wireless compliance
Minimum 6 years' experience working with/for an accredited EMC/wireless test house including medical and non-medical device test projects and approval processes
Demonstrated knowledge of computers, electronics, servo-mechanical devices, and standard software applications
Ability to read and interpret electronic schematics
Excellent system trouble shooting skills to FRU (or component) level
Excellent verbal, presentation and written communication skills with an ability to relate to different people
A real excitement to learn and get to the bottom of problems
Strong track record of continuous improvement initiative
Preferred
Experience with PDM tools such as Agile is a plus
Experience working with UL, CSA, and IEC product safety projects and approval processes including UL Follow-Up Service (FUS) procedures is a plus
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
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
GlobeNewswire
2026-01-23
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2026-01-16
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