Hardware Compliance Engineer - EMC/Wireless & Safety

Intuitive; Sunnyvale (CA); Presencial; USD 143.000 - 168.000; Jornada completa

Descripción de la vacante

Intuitive Surgical is seeking a Hardware Compliance Engineer to drive EMC/wireless compliance, regulatory testing, and certification processes for medical devices. You will coordinate with design teams, labs, and regulatory bodies to ensure timely approvals and maintain rigorous documentation.

Role involves working with UL/FUS procedures, environmental testing, and continuing education on medical standards.

Formación

• Associates Degree or Bachelors Degree preferred in electronic, mechanical, or biomedical engineering, or equivalent degree.
• Demonstrated knowledge of EN60601-1 and EN60601-1-2 for Medical Equipment Safety and EMC/wireless compliance
• 5+ years’ experience with accredited EMC/wireless test houses including medical/non-medical device approvals
• 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 level

Responsabilidades

• Drive EMC/wireless compliance and support design for non-FDA regulatory compliance (Safety and EMC/wireless) with cross-disciplinary teams
• Lead regulatory verification activities for new and sustaining products
• Define and develop test plans, conduct compliance testing, and resolve mechanical, EMI and safety problems
• Coordinate with NRTLs for product certification and regulatory approvals, including scheduling labs and validating test results
• Provide technical support for UL Follow-Up Service (FUS) inspections
• Maintain documentation for certifications and issue resolution with engineering/manufacturing
• Create design validation, risk analysis, and design review documentation
• Stay updated on EMC/wireless and Safety medical standards and testing procedures
• Suggest process improvements and escalate technical issues to engineering/manufacturing
• Provide safety and EMC/wireless input during product development for new/upgraded products
• Lead global EMC and wireless certification activities for products with wireless components
• Prepare, review and submit documentation to regulatory agencies (FCC, CE RED, KC, etc.)
• Manage EMC/wireless certification records across product lines
• Communicate with regulatory bodies during post-market surveillance/audits
• Identify country-specific EMC/wireless requirements for new markets
• Educate internal teams on EMC/wireless certification requirements

Conocimientos

EMC/wireless compliance

Regulatory testing

Electrical schematics

Troubleshooting

Lab coordination

Cross-functional collaboration

Educación

Electrical/Biomedical/electronic engineering degree (preferred)

Herramientas

Agile

Descripción del empleo

Intuitive Surgical is seeking a Hardware Compliance Engineer to drive EMC/wireless compliance, regulatory testing, and certification processes for medical devices. You will coordinate with design teams, labs, and regulatory bodies to ensure timely approvals and maintain rigorous documentation.

Role involves working with UL/FUS procedures, environmental testing, and continuing education on medical standards.