Hardware Compliance Engineer

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive is seeking a Hardware Compliance Engineer to drive EMC and wireless verification and safety test support for our advanced medical devices. You will lead interactions with outside labs and regulatory bodies, ensuring product compliance across platforms and environments.

You will develop test plans, track certifications, and maintain documentation while collaborating with Engineering, Manufacturing and Product Support teams to resolve complex EMI, safety, and labeling challenges.

Qualifications

• Experience with EMC/wireless verification for medical devices.
• Knowledge of safety testing standards is required.
• Ability to interact with external labs and regulatory bodies.

Responsibilities

• Drive EMC/wireless compliance for new and current product platforms.
• Coordinate regulatory verification activities (Safety and EMC/wireless).
• Develop test plans and lead efforts to resolve EMI and safety issues.
• Liaise with NRTLs and test labs to achieve certification.
• Maintain documentation for certifications and inspections.
• Educate teams on EMC/wireless requirements and best practices.

Skills

EMC testing

Wireless testing

Regulatory knowledge

Project coordination

Documentation

Job description

Job Description

Primary Function of Position:

The Hardware Compliance Engineer works inside the Design Engineering group which is responsible for the development of the Hardware and Software associated with Intuitive Surgical products. The Hardware Compliance Engineer will be responsible for EMC/wireless verification and Safety test support for new and current product platforms. This self-motivated, hands-on engineer will be an integral part of the HW Compliance group, leading the interaction with outside labs and agencies. A successful candidate will be highly organized and capable of tracking multiple projects through varying stages of development, while maintaining day-to-day oversight of existing products standards compliance. This role will be interfacing closely with Engineering, Manufacturing and Product Support groups in the organization to help them isolate and fix tough system problems related to product EMC/wireless and Safety. Additional responsibilities include environmental testing, wireless co-existence testing, OEM HW, electro-mechanical design and reliability enhancements.

Roles and 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