Senior Hardware Compliance Engineer

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 143,000 - 168,000; Full time

Job summary

Intuitive Surgical is seeking a seasoned EMC/wireless certification specialist to drive compliance for medical devices, coordinating with international teams and labs to secure product approvals. The role emphasizes Deep knowledge of EN60601 standards, UL/FUS procedures, and hands-on test planning and documentation.

You will lead multi-country certification efforts, maintain records, educate teams, and liaise with agencies (FCC, CE RED, MIC, KC, SRRC, etc.).

Qualifications

• Associates Degree or Bachelors Degree preferred in electronic, mechanical, or biomedical engineering, or equivalent degree or equal experience.
• Demonstrated knowledge of 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 with UL, CSA, and IEC product safety projects and approval processes including UL Follow-Up Service (FUS) procedures is a plus
• 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

Responsibilities

• Drive EMC/wireless compliance and support projects in design for non-FDA regulatory compliance with cross-country teams to achieve certification.
• Drive regulatory verification activities for Safety and EMC/wireless for new products and sustaining activities.
• Define and develop test plans, conduct compliance testing, and lead efforts to solve mechanical, EMI and safety problems.
• Coordinate with product development teams and NRTLs to achieve product certification and regulatory approvals including scheduling test labs.
• Provide technical support for UL Follow-Up Service inspections.
• Maintain documentation to achieve product certifications and resolve issues with engineering and manufacturing.
• Create documentation for design validation, risk analysis, and design review.
• Maintain knowledge of EMC/wireless and Safety medical standards and testing procedures.
• Lead Global EMC and wireless certification activities for Intuitive products with wireless components.
• Prepare, review and submit technical documentation to regulatory agencies and certified bodies.
• Manage EMC and wireless certification records for all applicable product lines.
• Communicate with regulatory agencies during post market surveillances/audits.
• Identify country-specific EMC/wireless labeling needs for new markets.
• Educate internal teams on EMC and wireless certification requirements and best practices.
• Lead Global EMC and wireless certification activities for Intuitive products with wireless components (e.g. WLAN, Bluetooth, etc.)

Skills

EMC/Wireless

Regulatory compliance

Medical device experience

UL/IEC knowledge

Education

Associate or Bachelor degree in engineering

Tools

Agile

PDM tools

Job description

• Ways of Working: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type: Employee
• Min. Salary Region 1: 168100 USD
• Global Job Level (HCM): Professional 4 (11)
• Min. Salary Region 2: 142900 USD

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

Roles and Responsibilities:

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.

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 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 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

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

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.

U.S. Export Controls Disclaimer:In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending
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 at [e-mail].

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.