Staff Engineer - Medical Device

UL Solutions•Brea, CA

2d•Hybrid

About The Position

This is a hybrid role requiring 3 days onsite in Brea, CA. Responsibilities include representing UL on harmonized standards development committees, delivering technical training content to customers or at public events, and independently determining project scope, developing investigation plans, and defining project specifications. Projects may involve travel for testing at client sites. The role requires initiating and following up on client communication, discussing technical issues, explaining UL procedures, conveying project costs, and negotiating completion dates. It also involves addressing client concerns, resolving issues, and providing technical assistance regarding product inspection and follow-up services. The engineer will establish appropriate test programs, examine samples for compliance with UL requirements, and coordinate complex laboratory activities, including directing and reviewing the work of technicians and engineering assistants. The role may involve conducting testing, coordinating administrative aspects of project management, serving as Project Handler or Reviewer, and communicating project status and results through reports. Responsibilities also include preparing Follow-Up Service Procedures, integrating continuous improvement, resolving engineering issues related to Variation Notices, assisting in the development of UL requirements and special test methods/equipment, analyzing test program adequacy, and potentially performing File Reviews. The position may involve representing UL at industry functions, providing complex sales support, directing and reviewing assigned staff, training various personnel, and providing technical assistance in multiple product categories. Additionally, the role includes performing quality systems and technical audits of customer laboratories and other duties as directed.

Requirements

University Degree in Electrical Engineering or related field.
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.
Demonstrated ability to apply project-handling concepts in use in areas of expertise, including application to complex, new, or unusual products.
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.
Able to provide unique solutions to complex problems.

Responsibilities

Represents UL on harmonized standards development committees.
Delivers technical training content to customers or at public events.
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.
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.
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.