Senior Hardware Compliance Engineer

Intuitive; Sunnyvale (CA); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Intuitive seeks a regulatory engineering professional to drive EMC and wireless certification for its products. You will lead verification activities, define test plans, and resolve EMI/safety issues in collaboration with cross-functional teams and external labs.

You will coordinate with NRTLs, prepare regulatory submissions, and maintain documentation for certifications across multiple markets, ensuring post-market surveillance and adherence to standards.

Competenze

• Experience driving EMC/wireless compliance testing and regulatory verification activities.
• Knowledge of global regulatory bodies and certification processes (FCC, ISED, CE RED, etc.).
• Ability to develop test plans and lead corrective actions for EMI/safety issues.
• Experience coordinating with NRTLs and test labs for product certification.

Mansioni

• Drive EMC/wireless compliance and support non-FDA regulatory compliance with multi-disciplinary teams across countries.
• Lead regulatory verification activities for new products and sustaining platforms.
• Define and develop test plans, conduct compliance testing, and solve EMI and safety problems.
• Partner with product development teams and NRTLs to achieve certification and approvals, including scheduling labs and reviewing readiness.
• Provide technical support for UL FUS inspections and maintain certification documentation.
• Create design validation, risk analysis, and design review documentation.
• Advise on EMC/wireless standards knowledge and testing procedures; push for process improvements.

Conoscenze

EMC testing

Regulatory compliance

Test planning

NRTL coordination

Documentation & records

Cross-functional collaboration

Liaison with regulatory bodies

Post-market surveillance

Descrizione del lavoro

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