Project Engineer-Medical Devices

JOB DESCRIPTION
UL is currently seeking a motivated Electrical Engineer focusing on medical device evaluation and testing in the heart of medical alley in Mounds View, Minnesota. This position provides a small business feel, but with all of the support, resources and other benefits of a large corporation. It will include hands-on laboratory engineering that requires testing products for fire, electrical, and mechanical hazards, which can sometimes result in catastrophic failures.
The position is HYBRID, individuals are required to be on-site 3 days a week in Minneapolis, MN
RESPONSIBILITIES
Under minimal supervision, independently manage and execute timely completion of engineering safety investigations for a wide variety of cutting-edge medical products, laboratory equipment, and consumer technology equipment. Complete investigations by analyzing project scope, determining project specifications, designing testing programs, analyzing test programs for adequacy and sequence, examining samples for compliance with global UL safety requirements, and preparing test reports for clients. Assist in the development of UL requirements, test methods, and test equipment. Exercise Project Handler Signature Authority as Project Handler of record responsible for opening, maintenance, completion, and closing of assigned new work engineering projects. May exercise Review Signature Authority as assigned as Reviewer of record responsible for initial review, status review, and final technical review of new work engineering projects. Project Engineers should also be prepared for work in a laboratory environment, with hands on work in determining the safety of products.

• 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, including mechanical drawings and electrical schematics. 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, including IEC 60601-1, ISO 14971, IEC 61010-1, and IEC 62368-1.
• Examines samples for compliance with UL requirements and 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 complex laboratory activities by preparing data sheets and instructions to technicians, scheduling and reviewing work of Laboratory Technicians and engineering support staff, establishing completion dates, and often conducting the testing. 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. 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.
• Provides complex sales support such as giving presentations during client visits.
• Performs quality systems and technical audits of customer laboratories.
• May direct 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.

QUALIFICATIONS

• Bachelor's degree in Electrical Engineering or Biomedical Engineering with Electrical focus from an ABET accredited program
• 3-7 years directly related experience
• Working knowledge of core conformity standards IEC 60601-1, ISO 14971, and IEC 61010-1
• Detailed knowledge of the technical vocabulary common to the appropriate discipline
• Demonstrated ability to apply project-handling concepts in use in areas of expertise
• Working knowledge of industry issues, needs, and problems
• Basic knowledge of laboratory testing apparatus and techniques common to the appropriate discipline
• Strong communication skills and ability to interact and connect with customers
• Desire to work within a team environment
• Comfortable in laboratory environments performing hands-on engineering