Project Engineer - 医疗器械

JOB DESCRIPTION

• 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.

RESPONSIBILITIES
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.
QUALIFICATIONS

• 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.

ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
ABOUT THE TEAM
Every product needs to be safe. But for medical devices, it's absolutely essential. For manufacturers, getting medical devices approved can be incredibly complex. That's where our team of experts comes in. Together, we help improve medical outcomes. We test, advise and use our world-class knowledge to help manufacturers navigate changing standards and regulations, so they can provide people around the world with innovative products that save and improve lives. Whether it's equipment to help someone walk again or an incubator for a premature baby, our experts are behind them all, helping to ensure their safety. Join our team, connect with global experts and help shape the next generation of medical technology.