Senior Hardware Compliance Engineer

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

Skill/Job Requirements:

In order to adequately perform the responsibilities of this position the individual must:

• 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

• Experience with PDM tools such as...