Senior Project Engineer, Medical Devices

JOB DESCRIPTION
Due to expansion within our Consumer, Medical & Information Technologies division, we are currently seeking an experienced Senior Project Engineer who possesses extensive knowledge and experience with the IEC/UL 60601-1 (Medical Electronic Equipment) standards to provide support for our customers within the European Life & Health Safety Business.
RESPONSIBILITIES

• Independently determines project scope, develops a preliminary plan of investigation, and determines project specifications such as cost, time, and sample requirements by analyzing client input, available supplemental data, and product construction.
• Projects may include frequent travel to conduct or witness tests at client sites. 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, convey project cost, and negotiate completion date and sample requirements.
• Acts to address client concerns and to resolve complex client issues.
• Provides technical assistance to clients in reference to product inspection and follow-up services.
• Establishes appropriate test programs by reviewing files and manufacturer's information, examining samples, and applying UL requirements.
• Determines areas in which the product is not in compliance with UL requirements or of any changes in project scope or specifications and notifies client.
• Coordinates complex laboratory activities by preparing data sheets and instructions to technicians and by establishing completion dates.
• Coordinates administrative aspects of project management.
• Serves as Project Handler of record and signs as Reviewer of record as assigned.
• Communicates project status and results to clients through frequent contact and by preparing reports.
• Prepares Follow-Up Service Procedures and information pages.
• 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.
• Coordinates and/or performs File Reviews.
• May represent UL on technical committees and/or industry-related functions such as seminars and trade shows.
• May provide direction as a Primary Designated Engineer or Designated Engineer for specific product categories.
• Directs and reviews work of assigned staff.
• Trains office, field, and/or laboratory staff and entry level engineers.
• Provides technical assistance in several product categories, operations or systems to laboratory and/or field staff.
• Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.
• Performs other duties as directed.

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QUALIFICATIONS

• University Degree in Engineering, Engineering Technology, Industrial Technology, Manufacturing Technology, or Physics from an ABET-accredited program plus directly related work experience.
• Proven experience as a Project Engineer gained in the electronic medical devices industry
• Extensive working knowledge and experience of of conformity standards: IEC/EN/UL 60601-1
• Experience with particulars and collateral standards
• Experience of conformity standards: IEC/EN/UL 61010-1.
• Detailed knowledge of the technical vocabulary common to the appropriate discipline.
• Demonstrated ability to apply project-handling concepts in use in the area of expertise
• Willing to travel

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 come 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.