Senior Project Engineer - Medical Regulatory Services

UL Solutions•United States,

1d•Remote

About The Position

The Senior Project Engineer works on UL Solutions’ Medical Regulatory Services team, which supports patient safety and timely global market access for medical device products under certification schemes including ISO 13485, INMETRO, UKCA, CE Marking, and MDSAP. This is a home-based role requiring 50–75% domestic and international travel. The position coordinates or performs audits and technical file reviews, manages project scope and administrative coordination, and communicates project status, results, technical requirements, and compliance findings to clients. It also addresses complex client concerns and engineering issues, develops requirements and special test methods for products that fall outside existing standards, and may represent UL at technical committees and industry events. The role directs and reviews the work of peer auditor staff.

Requirements

University degree in Engineering, Biomedical Engineering, Biochemistry, Health Sciences, or Physics from an accredited program.
At least 4 years of experience in the medical device field, including at least 2 years of hands-on medical device design, manufacturing, testing, or clinical evaluation experience.
Knowledge of business processes and application of quality management standards.
Good verbal and written communication skills and attention to detail.
Working knowledge of conformity standards in areas of expertise.
Ability to apply project-handling concepts in areas of expertise, including to complex, new, or unusual products.
Working knowledge of industry issues, needs, and problems.
Ability to travel 50–75% domestically and internationally.
Unrestricted USA state-issued driver's license.
Unrestricted valid USA passport.

Nice To Haves

Good public speaking and business development skills.

Responsibilities

Coordinate and/or perform audits and technical file reviews.
Plan and schedule workloads to make best use of time and maximize revenue-earning activity.
Initiate communication with clients to promote and explain the benefits of new and existing services.
Follow up on client contacts.
Discuss technical issues with clients, explain UL procedures and requirements, and convey project scope.
Address client concerns and resolve complex client issues.
Provide technical assistance to clients regarding medical regulatory services.
Establish appropriate project scope by reviewing files and manufacturer information, examining documentation, and applying UL requirements.
Identify areas where a product or quality management system does not comply with UL or regulatory requirements, or where project scope or certification has changed, and notify the client.
Coordinate administrative aspects of project management.
Communicate project status and results to clients through frequent contact and reports.
Integrate continuous improvement concepts and techniques into all aspects of the job.
Resolve complex engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of variations.
Develop UL requirements for testing products beyond existing standards or involving unique features that require frequent independent judgment.
Develop special test methods and test equipment.
May represent UL on technical committees and/or at industry functions such as seminars and trade shows.
Direct and review the work of peer auditor staff.
Perform other duties as directed.