Hardware Compliance Engineer

Hardware Compliance Engineer

Sunnyvale, CA, United States

Not Remote

Engineering

JOB218254

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 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

Qualifications

Skill/Job Requirements:

• Associates Degree or Bachelors Degree preferred in electronic, mechanical, or biomedical engineering, or equivalent degree.
• Demonstrated knowledge of

Requirements

• Standards EN60601-1 and EN60601-1-2 for Medical Equipment Safety and EMC/wireless compliance
• 5+ 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

Nice to have:

• 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

• Experience working with UL, CSA, and IEC product safety projects and approval processes including UL Follow-Up Service (FUS) procedures is a plus

• Additional Information

• Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

• This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills.

• Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.

• accommodation & accessibility notice

• Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services.

• We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

• Base Compensation Range Region 1: 168,100 USD - 241,900 USD

• Base Compensation Range Region 2: 142,900 USD - 205,600 USD

• Shift: Day

• Workplace T