Product Safety and Regulatory Engineer

  • VAREX IMAGING CORPORATION
  • Salt Lake City, UT, USA
  • Jul 03, 2021

Job Description

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SummaryVarex Imaging Corporation is a leading innovator, developer, and manufacturer of X-ray imaging component solutions, which includes X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. With a 65+ year history of successful innovation, you will find our components in countless medical, industrial, and security imaging applications worldwide. Our mission states that through the talent of our people and vision of customers, we help improve and save lives throughout the world by making the invisible visible. Our values of Excellence, People, Innovation, and Customer are foundational to our success in upholding our mission.  We cannot make the invisible visible and uphold our mission without our EPIC employees, who deliver cutting edge technology globally, consistently pursue the highest quality standards, engage in a diverse and ethical workforce, inspire innovation, and showcase a customer mindset. We strive every day to make a difference in the lives of both our customers and theirs.
Job Description
Varex Imaging Product Safety & Regulatory Engineer is responsible for driving product safety design and certification efforts for X-Ray Imaging components used in Medical and Security & Industrial applications marketed world-wide. In addition:
* Partner with development and laboratory technicians to provide technical support, mentorship, regulatory guidance, and oversight for Safety (NRTL) and EMC testing including EMC and Safety test plans, working with test lab/test sites as well as completing hands-on work performing safety risk assessments
* Help drive and translate applicable requirements of IEC 60601 and collateral standards, ISO 9001, IEC 61010, and other applicable standards related to medical and Industrial product safety into design requirements
* Identify product safety requirements to achieve compliance in all applicable countries
* Provide guidance and direction on maintaining alignment to relevant safety and regulatory standards, including upcoming changes to applicable standards
* Ensure that products post-release continue to meet evolving safety standards and regulations, as well as incorporating any learnings from field data into continuous product improvements
* Provide guidance to project leaders and engineers regarding safety requirements including tests and design constraints to ensure the product satisfies the various national and international safety regulations
* Review and approve UL test data generated by internal and external laboratories
* Submit test data packets to UL, request quotes, manage final reports and safety certificates
* Support customers, internal and external, on UL safety reports, certifications, and other related requests
* Understand manufacturing processes to identify and address process/practice protocols that can lead to product safety or compliance issues
* Review and approve design outputs with an emphasis on product safety and compliance
* Review engineering change orders on critical-to-safety parts to assess the level of risk and ensure that appropriate verification is completed prior to release
* Participate in any product safety critical issues and provide mentorship on containment and corrective actions
* Perform product safety testing, including preparation of test sample(s), execution of the test(s), test reporting and data analysis
* Help determine and facilitate Field... For full info follow application link.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.