Engineer Project Associate - Medical Device

JOB DESCRIPTION

• 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 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.
• Is familiar with applicable standards, company manuals and appropriate technical literature.
• Examines samples for compliance with UL requirements and notifies client of any areas in which the product is not in compliance 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 engineering 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.
• Assists in the development of UL requirements.
• Assists in developing special test methods and test equipment.
• Analyzes test program for adequacy and sequence.
• May coordinate and/or perform File Reviews, as directed.
• May represent UL at industry related functions such as seminars and trade shows.
• Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.
• Performs other duties as directed.

QUALIFICATIONS

• University Degree in Engineering, Engineering Technology, Industrial Technology, Manufacturing Technology, or Physics from an accredited program plus two years directly related experience.
• Experience in testing/certification of Medical Electrical Equipment as per 60601, main, particular and collateral standards. Experience in standards for radiology equipment, ECG and Patient Monitoring system will be an added advantage.
• Detailed knowledge of the technical vocabulary common to the appropriate discipline.
• Knowledge of laboratory testing apparatus and techniques common to the appropriate discipline.

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.