Senior Hardware Compliance Engineer

Intuitive•Sunnyvale, CA

17h•$142,900 - $241,900•Onsite

About The Position

This position has responsibility for driving EMC/wireless compliance and supporting projects in design for non-FDA regulatory compliance (Safety and EMC/wireless) with multi-disciplinary project teams in other countries with the goal of achieving certification. The role involves driving regulatory verification activities for new products and sustaining activities of current platforms. The engineer will define and develop test plans, conduct compliance testing, and lead efforts to solve mechanical, EMI and safety problems. This role requires partnering 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. Additionally, the position provides technical support for UL Follow-Up Service (FUS) quarterly inspections, maintains accurate documentation of all actions required to achieve product certifications and resolve issues, and creates documentation to include design validation, risk analysis, and design review. The engineer will maintain current knowledge of EMC/wireless and Safety medical standards and testing procedures, make recommendations for process improvements, and provide safety and EMC/wireless input to product development/design activities. This role leads Global EMC and wireless certification activities for products with wireless components and prepares, reviews, and submits technical documentation to regulatory agencies and certified bodies. The engineer will manage EMC and wireless certification records, communicate with regulatory agencies and certified bodies during post-market surveillances/audits, identify country-specific compliance needs, and educate internal teams on certification requirements and best practices.

Requirements

Associates Degree or Bachelors Degree preferred in electronic, mechanical, or biomedical engineering, or equivalent degree or equal experience.
Demonstrated knowledge of Requirements Standards EN60601-1 and EN60601-1-2 for Equipment Safety and EMC/wireless compliance
8 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.
Experience working with UL, CSA, and IEC product safety projects and approval processes including UL Follow-Up Service (FUS) procedures is a plus

Nice To Haves

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 Agile is a plus

Responsibilities

Driving EMC/wireless compliance and supporting projects in design for non-FDA regulatory compliance (Safety and EMC/wireless) with multi-disciplinary project teams in other countries with the goal of achieving certification.
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