Senior Project Engineer - Medical Devices

UL Solutions • Minneapolis, MN

5h • $103,000 - $130,000

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 projects from scope definition and planning through testing, review, and reporting, while coordinating laboratory work and communicating with clients about technical issues, requirements, costs, timelines, and results. Projects may involve travel to conduct or witness testing at client sites.

The Senior Project Engineer applies applicable UL requirements and medical-device standards, examines product samples, assesses compliance, and resolves engineering issues. The role may act as Project Handler or Reviewer of record, develop requirements and test methods, support complex sales activities, and direct, review, and train assigned staff. It also performs technical and quality-system audits of customer laboratories and incorporates continuous improvement into its work.

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.
• Initiative and resourcefulness.
• Strong communication skills and ability to interact and connect with customers.
• Proven ability to be innovative and creative.
• Desire to work in 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 Evaluator and Reviewer experience with 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, including cost, timing, and sample requirements.
• Communicate with clients about services, technical issues, UL procedures and requirements, project costs, completion dates, sample requirements, and concerns; provide technical assistance on product inspection and follow-up services.
• Establish test programs by reviewing files and manufacturer information, examining samples, and applying UL requirements; identify product noncompliance and changes in project scope or specifications.
• Coordinate complex laboratory activities, including preparing data sheets and technician instructions, scheduling and reviewing work, and setting completion dates; conduct testing when needed.
• Coordinate administrative project-management activities and serve as Project Handler of record and/or Reviewer of record when assigned.
• Keep clients informed of project status and results, prepare reports, and prepare Follow-Up Service Procedures and information pages.
• Apply continuous-improvement concepts and techniques to the work.
• Analyze and report on the acceptability of variations associated with Variation Notices.
• Assist in developing UL requirements, special test methods, and test equipment; assess test-program adequacy and sequence; coordinate or perform File Reviews as directed.
• Represent UL at industry functions such as seminars and trade shows, when appropriate.
• Provide complex sales support, including presentations during client visits.
• Direct and review assigned staff’s work; train office, field, and/or laboratory staff and entry-level engineers; provide technical assistance across product categories, operations, or systems.
• 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, including mental and financial health benefits.
• 401(k) retirement savings.
• Paid time off for full-time employees, including 15 vacation days, 12 holidays (including floating holidays), and 80 hours of sick time off.

What This Job Offers

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