Senior Hardware Compliance Engineer

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position:
The Senior 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:

This position has responsibility and authority for:

• 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

Qualifications

Skill/Job Requirements:<