[Remote] Senior Project Engineer - Medical Regulatory Services

Note: The job is a remote job and is open to candidates in USA. UL Solutions is hiring a Senior Project Engineer for its Medical Regulatory Services team. The role supports medical-device market access and patient safety by coordinating or conducting audits and technical file reviews, managing client projects, and providing regulatory and engineering guidance.

Responsibilities

• Coordinates and/or performs Audits and Technical File Reviews
• Plan/schedule workloads to make best use of own time and maximize revenue-earning activity
• 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, and convey project scope
• Acts to address client concerns and to resolve complex client issues
• Provides technical assistance to clients in reference to medical regulatory services
• Establishes appropriate project scope by reviewing files and manufacturer's information, examining documentation, and applying UL requirements
• Determines areas in which the product and QMS is not in compliance with UL and regulatory requirements or of any changes in project scope or certification and notifies client
• Coordinates administrative aspects of project management
• Communicates project status and results to clients through frequent contact and by preparing reports
• Integrates continuous improvement concepts and techniques into all aspects of the job
• Resolves complex engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations
• Develops UL requirements for testing products beyond the scope of existing standards, or those involving unique features requiring frequent use of independent judgment
• Develops special test methods and test equipment
• May represent UL on technical committees and/or industry-related functions such as seminars and trade shows
• Directs and reviews work of peer auditor staff
• Performs other duties as directed

Skills

• University Degree in Engineering, Biomedical Engineering, Biochemistry, Health Sciences, or Physics from an accredited program
• Minimum of 4 years experience in the medical device field including at least 2 years must be 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 an eye for detail
• Working knowledge of conformity standards in use in areas of expertise
• Demonstrated ability to apply project-handling concepts in use in areas of expertise including application to complex, new, or unusual products
• Working knowledge of industry issues, needs, and problems
• Ability to travel 50-75% domestically and internationally
• USA state issued driver's license without restrictions
• Valid USA passport without restrictions
• Good public speaking and business development skill will be considered advantageous

Benefits

• Home-based role

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