Senior Project Engineer - Medical Devices

UL Solutions • Minneapolis, MN

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About The Position

UL’s Consumer, Medical and Information Technology (CMIT) team is seeking an experienced engineer to conduct safety investigations of medical devices. The role manages complex projects from planning and client communication through testing, review, and reporting. It includes establishing project scope, plans, specifications, and test programs; examining samples for compliance with UL requirements; coordinating laboratory work; and providing technical assistance to clients and staff. Projects may involve travel to conduct or witness testing at client sites, and the engineer may also perform testing hands-on in a laboratory.

The Senior Project Engineer may serve as Project Handler or Reviewer of record, direct and review assigned staff, train employees and entry-level engineers, and support continuous improvement and development of UL requirements, test methods, and equipment. The role also includes resolving engineering issues, conducting customer laboratory audits, supporting clients through presentations, and representing UL at industry events.

Requirements

• University degree in Electrical Engineering or a related field from an ABET-accredited program.
• At least 5 years of Compliance Engineering experience as an Evaluator and Reviewer in IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-11.
• Demonstrated ability to apply project-handling concepts in areas of expertise, including to complex, new, or unusual products.
• Strong communication skills and ability to interact and connect with customers.
• Initiative and resourcefulness.
• Ability to be innovative and creative.
• Desire to work within a team environment.
• Comfort working hands-on in laboratory environments.
• Excellent interpersonal skills.
• Ability to lead in a technical environment.
• Ability to provide unique solutions to complex problems.

Nice To Haves

• Additional experience as an Evaluator and Reviewer in IEC 60601 series particular standards, including 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, and IEC 60601-1-3.

Responsibilities

• Determine project scope, develop preliminary investigation plans, and establish project specifications such as cost, schedule, and sample requirements.
• Communicate with clients about services, technical issues, UL procedures and requirements, project costs, completion dates, and sample requirements; address concerns and resolve issues.
• Provide technical assistance to clients regarding product inspection and follow-up services.
• Establish test programs by reviewing project files and manufacturer information, examining samples, and applying UL requirements.
• Examine samples for compliance and notify clients of noncompliance or changes to project scope or specifications.
• Coordinate complex laboratory activities, including preparing data sheets and technician instructions, scheduling and reviewing work, and setting completion dates; sometimes conduct testing.
• Coordinate administrative aspects of project management and, as assigned, serve as Project Handler of record and/or Reviewer of record.
• Communicate project status and results to clients through frequent contact and written reports.
• Prepare Follow-Up Service Procedures and information pages.
• Apply continuous improvement concepts and techniques to all aspects of the job.
• Resolve engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of variations.
• Assist in developing UL requirements, special test methods, and test equipment.
• Analyze test programs for adequacy and sequence and, as directed, coordinate and/or perform File Reviews.
• Represent UL at industry-related seminars, trade shows, and other functions.
• Provide complex sales support, including presentations during client visits.
• Direct and review assigned staff; train office, field, and/or laboratory staff and entry-level engineers.
• Provide technical assistance across product categories, operations, or systems to laboratory and/or field staff.
• Perform quality systems and technical audits of customer laboratories.
• Perform other duties as directed.

Benefits

• Annual bonus compensation with a target payout of 10% of base salary.
• Medical, dental, and vision benefits.
• Wellness benefits for mental and financial health.
• Retirement savings (401K).
• Paid time off for full-time employees, including 15 vacation days, 12 holidays (including floating holidays), and 80 hours of sick time.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior