Senior Project Engineer - Medical Regulatory Services

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.

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.

Qualifications

• 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.

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.