JOB OVERVIEW: Compliance Engineer 2 China 3rd Edition compliance, coordinates third-party test labs for safety and EMC compliance testing for medical electrical systems used at Natus, and determine standards gap assessments. ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned. ·Support compliance and regulatory activities for China Standards and EU Harmonized standards including safety and EMC testing & certification, product configuration, risk management, Usability Engineering, and technical support and troubleshooting at the lab. ·Provide guidance to less experienced engineers and contractors. ·Manage Follow-up services/inspections with type testing labs in China, National Certified Body (CB) and CB Testing Laboratories (e.g., UL, Intertek, Nemko, TUV) and 3rd party test reports and certifications. ·Take ownership corrective and preventive action (CAPA) by conducting root cause investigation, prepare CAPA plan, coordinate task with the cross-functional team during implementation actions and effectivity check. ·Analyze highly complex engineering problems and troubleshooting electrical issues related to production, customer complaints, supplier quality, or other sources; and initiating engineering change requests (ECR), completing engineering change orders (ECO). ·Determine standards gap assessments applicable to Natus products and determine required documentation updates and product testing impact. When testing is required, follow-up on activities to be performed by raising change requests (ECRs), updating product DHF, and coordinating EU MDR Technical Documentation File updates with regulatory affairs. ·Provide engineering support for domestic and international product registrations with emphasis on requirements for China, Korea, and Brazil. ·Participate in quality improvement, complaints investigation, change control, and safety assessment processes. ·Stay up-to-date and follow all Quality System procedures related to their jobs which can affect the quality of products or services provided to our customers. ·Self-prioritize deliverables based on level of urgency. ·Leading the review of system use requirement specification and product requirements Document for the transferred products. ·Responsible for the Critical material identification and review system bill of material. ·Responsible for product risk management planning and the writing of risk management reports ·Responsible for the design and development review of each stage, process validation protocol and prototype sample review. Travel Required  Some travel is expected (up to 25%) QUALIFICATION REQUIREMENTS: ·Bachelor’s degree in an engineering field ·Minimum 5 years of Experience ·Familiarity with design controls, design history files, and technical files ·Thorough understanding of safety & EMC testing ·Working experience with product lifecycle management (PLM) ·Ability to communicate technical knowledge in a clear and understandable manner ·Creativity and analytical skills ·Ability to communicate technical knowledge in a clear and understandable manner ·Familiarity with China, FDA and EU regulatory & compliance requirements Natus Medical is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status. #LI-SH1