Senior Project Engineer - Medical Devices

UL’s Consumer, Medical and Information Technology (CMIT) team is currently seeking an experienced candidate interested in conducting safety investigations of Medical Devices!

This is a hybrid role requiring 3 days per week in office.

• Extensive knowledge of IEC and UL standards and international safety schemes such as OSHA's NRTL (Nationally Recognized Testing Laboratories) Program and the IECEE's CB Scheme preferred.
• 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 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 complex laboratory activities by preparing data sheets and instructions to technicians, scheduling and reviewing work of laboratory technicians and engineering assistants and establishing completion dates. May sometimes conduct the testing.  Coordinates administrative aspects of project management. May serve as Project Handler of record and/or 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.
• Provide complex sales support such as giving presentations during client visits.
• Directs and reviews work of assigned staff.  Trains office, field, and/or laboratory staff and entry level engineers. Provides technical assistance in several product categories, operations or systems to laboratory and/or field staff.
• Performs quality systems and technical audits of customer laboratories.
• Performs other duties as directed.

• University Degree in Electrical Engineering, Biomedical Engineering, Engineering Technology, or related field, from an ABET accredited program preferred.
• 10 years of Compliance Engineering experience as Evaluator and Reviewer in the following core standards:  IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11.
• Additional experience as Evaluator and Reviewer in 60601 series particular standards, such as IEC 60601-2-2, IEC 60601-2-18, IEC 60601-2-47, ISO 80601-2-56, ISO 80601-2-61, ISO 80601-2-12, ISO 80601-2-74, IEC 60601-2-77, IEC 60601-2-78, IEC 60601-2-33, IEC 60601-2-37, IEC 60601-2-43, IEC 60601-2-44, IEC 60601-2-45, IEC 60601-2-37, IEC 60601-1-3.
• Detailed knowledge of the technical vocabulary common to the appropriate discipline.
• Working knowledge of conformity standards in use in areas of expertise.
• Demonstrated ability to apply project-handling concepts in use in areas of expertise, including application to complex, new, or unusual products.
• Working knowledge of industry issues, needs, and problems.
• Basic knowledge of laboratory testing apparatus and techniques common to the appropriate discipline.
• Shows initiative and resourcefulness.
• Strong communication skills and ability to interact and connect with customers.
• Proven ability to be innovative and creative.
• Desire to work within a team environment.
• Comfortable in laboratory environments performing hands-on engineering.
• Excellent interpersonal skills.
• Ability to lead in a technical environment.
• Able to provide unique solutions to complex problems.

What you'll experience working at UL:

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