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.