Project Engineer - 医疗器械

• Independently determines project scope, develops a preliminary plan of investigation, and determines project specifications such as cost, time, and sample requirements by analyzing client input, available supplemental data, and product construction.
• Projects may include frequent travel to conduct or witness tests at client sites.
• Initiates communication with clients to promote and explain the benefits of new and existing services.
• Follows up on contacts from clients.
• Communicates with clients to discuss technical issues, explain UL procedures and requirements, convey project cost, and negotiate completion date and sample requirements.
• Acts to address client concerns and to resolve client issues.
• Provides technical assistance to clients in reference to product inspection and follow-up services.
• Establishes appropriate test programs by reviewing files and manufacturer's information, examining samples, and applying UL requirements.
• Notifies client of any areas in which the product is not in compliance with UL requirements or of any changes in project scope or specifications.
• Coordinates laboratory activities by preparing data sheets and instructions to technicians, scheduling and reviewing work of Laboratory Technicians and support staff and establishing completion dates.
• Coordinates administrative aspects of project management.
• Serves as Project Handler of record and may sign as Reviewer of record as assigned.
• Communicates project status and results to clients through frequent contact and by preparing reports.
• Prepares Follow-Up Service Procedures and information pages.
• Integrates continuous improvement concepts and techniques into all aspects of the job.
• Resolves engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations.
• Proposes development of new and/or revised UL requirements.
• Develops special test methods and test equipment.
• Coordinates and/or performs File Reviews.
• May represent UL at industry related functions such as seminars and trade shows.
• May provide direction as a Primary Designated Engineer or Designated Engineer for specific product categories.
• May directs and review work of assigned staff.
• May train office, field, and/or laboratory staff and entry-level engineers.
• Provides technical assistance to laboratory and/or field staff.
• Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.
• Performs other duties as directed.

1. Handle projects: perform active medical device, IVDs or lab equipment construction check and tests, review test results and related technical documentation, issue test reports and complete projects within lead time;

2. Handle customers: arrange project in optimal way based on resources, solve technical queries in religious attitude, communicate in efficient way and maintain good partnership with customers;

3. Coordinate between team members and provide technical support to sales staff;

4. Perform other duties related to LHS testing business and accreditation tasks;

5. Share, exchange experience / standards / technical information with other colleagues.

1. Bachelor degree or above in Bio-medical /Electrical Engineering, Measurement Control and Instrument or equivalent;

2. Minimum 3 - 5 years’ experience in product safety testing and the medical/electronic industry, Knowledge of relevant regulations or standards for medical devices is preferred. (Standards: IEC 60601, IEC 61010 and so on);

3. Good team player , self-motivated and able to work independent;

4. Fluent in English and Mandarin;

5. Excellent client management and service skills.