The Engineer Project Associate is responsible for Medical Electrical Equipment Safety testing and evaluation according to relevant standards, manages project scope and communications with clients, coordinates laboratory activities, and ensures compliance with UL requirements, while also contributing to continuous improvement initiatives.
JOB DESCRIPTION
- Knowledge and experience in Medical Electrical Equipment Safety testing/evaluation as per IEC 60601-1 and Risk Management for Medical Devices as per ISO 14971. Experience in particular and collateral standards (IEC 60601-2-54, IEC 60601-2-43, IEC 60601-2-28, IEC 60601-1-3, IEC 60601-2-25, IEC 60601-2-27, IEC 60601-1-8, IEC 60601-1-6 and IEC 60601-1-11) will be an added advantage.
- Well versed with ISO/IEC 17025 requirements.
- 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 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 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.
- Is familiar with applicable standards, company manuals and appropriate technical literature.
- Examines samples for compliance with UL requirements and notifies client of any areas in which the product is not in compliance or of any changes in project scope or specifications.
- Coordinates laboratory activities by preparing data sheets and instructions to technicians, scheduling and reviewing work of laboratory technicians and engineering support staff and establishing completion dates.
- Coordinates administrative aspects of project management.
- Serves as Project Handler of record and may sign 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 engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations.
- Assists in the development of UL requirements.
- Assists in developing special test methods and test equipment.
- Analyzes test program for adequacy and sequence.
- May coordinate and/or perform File Reviews, as directed.
- May represent UL at industry related functions such as seminars and trade shows.
- Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.
- Performs other duties as directed.
QUALIFICATIONS
- Knowledge and experience in Medical Electrical Equipment Safety testing/evaluation as per IEC 60601-1 and Risk Management for Medical Devices as per ISO 14971. Experience in particular and collateral standards (IEC 60601-2-54, IEC 60601-2-43, IEC 60601-2-28, IEC 60601-1-3, IEC 60601-2-25, IEC 60601-2-27, IEC 60601-1-8, IEC 60601-1-6 and IEC 60601-1-11) will be an added advantage.
- Well versed with ISO/IEC 17025 requirements.
- University Degree in Engineering, Engineering Technology, Industrial Technology, Manufacturing Technology, or Physics from an accredited program plus two years directly related experience.
- Detailed knowledge of the technical vocabulary common to the appropriate discipline.
- Basic knowledge of laboratory testing apparatus and techniques common to the appropriate discipline.
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
Imagine getting your hands on new technology before it hits the shelves. To dig deep and figure out exactly how it works. That's what we do. We lift the lid and test the boundaries on a huge range of products, from health-monitoring smart watches monitoring to electric vehicles loaded with the latest software. We're always looking for people who are passionate about innovation, embrace change and love new and exciting challenges. Join our team, influence emerging technology and forge a successful career at the center of safety science.
Top Skills
Iec 60601-1
Iso 14971
UL Solutions Bengaluru, Karnataka, IND Office
Bengaluru, India
UL Solutions Bengaluru, Karnataka, IND Office
Bengaluru, India
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