Senior Project Engineer - Medical Devices

UL Solutions; Chicago (IL); On-site; USD 103,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Wellness benefits

401K retirement plan

Paid time off

Job summary

UL Solutions’ CMIT team seeks an experienced professional to conduct safety investigations of medical devices. You will independently define project scope, plan investigations, and coordinate testing with clients and UL staff.

Responsibilities include developing test programs, reviewing compliance, and communicating results. Strong engineering background and leadership are required to drive complex projects.

Qualifications

• ABET-accredited engineering degree required.
• 5+ years in compliance engineering as Evaluator/Reviewer for medical device standards like IEC 60601 series.
• Strong communication, initiative and problem-solving in a technical environment.

Responsibilities

• Define project scope and plan investigations with cost/time/sample considerations.
• Interact with clients to discuss issues, costs, and project timelines; provide technical assistance.
• Establish test programs and review files to ensure UL requirements.
• Coordinate laboratory activities and manage staff, schedules, and data.
• Prepare client reports and follow-up service procedures.

Skills

Analytical and problem solving skills

Coaching and mentoring

Collaboration skills

Communication skills

Data analysis

Engineering analysis

Engineering disciplines

Handling multiple tasks

ISO/IEC 17025

Laboratory safety

Lean Six Sigma

Microsoft Office

Planning abilities

Project development

Project management

Project management support

Requirement assurance

Software tools

Standards compliance

Technical troubleshooting

Time management

Education

ABET-accredited Electrical Engineering degree

Job description

Job Description

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

Responsibilities

• 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.

Qualifications

• University Degree in Electrical Engineering or related field, from an ABET accredited program.
• 5+ 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.
• 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 we offer:

Total Rewards: We understand compensation is an important factor as you consider the next step in your career . The estimated salary range for this position is $103,000-130,000 and is based on multiple factors, including job-related knowledge/skills, experience, geographical location, as well as other factors. This position is eligible for annual bonus compensation with a target payout of 10% of the base salary.

• This position also provides health benefits such as medical, dental and vision;
• Wellness benefits such as mental and financial health;
• Retirement savings (401K) commensurate with the standard rewards offered in each individual location or country.
• Paid time off including vacation (15 days), holiday including floating holidays (12 days) and sick time off (80 hours).

Required Skills

• Analytical and Problem Solving Skills
• Coaching and Mentoring
• Collaboration Skills
• Communication Skills
• Data Analysis
• Engineering Analysis
• Engineering Disciplines
• Handling Multiple Tasks
• ISO/IEC 17025
• Laboratory Safety
• Lean Six Sigma
• Microsoft Office
• Planning Abilities
• Project Development
• Project Management
• Project Management Support
• Requirement Assurance
• Software Tools
• Standards Compliance
• Technical Troubleshooting
• Time Management

About Us

A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.

About the Team

Every product needs to be safe. But for medical devices, it’s absolutely essential. For manufacturers, getting medical devices approved can be incredibly complex. That’s where our team of experts comes in. Together, we help improve medical outcomes. We test, advise and use our world-class knowledge to help manufacturers navigate changing standards and regulations, so they can provide people around the world with innovative products that save and improve lives. Whether it’s equipment to help someone walk again or an incubator for a premature baby, our experts are behind them all, helping to ensure their safety. Join our team, connect with global experts and help shape the next generation of medical technology.