Senior Project Engineer - Medical Regulatory Services

The Medical Regulatory Services team ensures patient safety while supporting timely market access for our clients' medical device products globally under a variety of certification schemes such as ISO 13485, INMETRO, UKCA, CE Marking and MDSAP.

This is a home-based role with a 50-75% travel requirement.

• 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.

• 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.

• Good public speaking and business development skill will be considered advantageous.

• Ability to travel 50-75% domestically and internationally.

• USA state issued driver's license without restrictions.

• Valid USA passport without restrictions.