職位描述
Description: Clinical Specialist is the end user representative in engineering organization. The main purpose of this role is to understand and support NPIs, give clinical guidance & evaluation from customer view. Provides internal test and validation,supports external evaluation in different life cycle for NPIs. Contribute clinical expertise in the team professional growth.Duties include (but are not limited to):• PRODUCT DEFINITION Participates in definition of the product, user requirements, product´s risk assessment, and the specifications during the engineering process.• CLINICAL EVALUATION & CONSULTING Co- work with engineering team, internal & external evaluation( IQ, usability, workflow, mechanical design, UI design…) with clinical expertise, give professional advice in different NPI mile stone.Differentiates the customer’s feedback.• CLINICAL VALIDATION Represents an end-user of the products within the engineering process. Knows the use of products including the surrounding environment and the customer needs. By participating in the integration process & validation helps the programs to identify clinically relevant issues for successful program integration within the scheduled time.• • CLINICAL EDUCATION Provides clinical training, hospital visit ,participates clinical activities,contributes expertise on both clinical & engineering team professional.Quality Specific Goals:1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position2. Complete all planned Quality & Compliance training within the defined deadlines3. Identify and report any quality or compliance concerns and take immediate corrective action as required4. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables5. Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possibleQualifications:1. QUALIFICATION: Bachelor degree or above. 2. LICENSE: CDFI License. 3. EXPERIENCE: Minimum 8 years ultrasound experience in hospital including echocardiogram experience. 4. LANGUAGE & COMMUNICATION: At least English reading skill,ability to communicate using English and/or local language.Preferred Qualifications:1. Medical company experience.2. Strong communication skill with both customers and engineers. 3. English communication skill.4. Ability to lead and supervise other clinical specialists
