Senior EMC & Wireless Compliance Engineer (Medical Devices)

Intuitive; 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

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.).