Safety Engineer

Role: Safety EngineerLocation: Dallas, TX – OnsiteDuration: 12 MonthsPrimary Job Function:Experience with Safety concepts, standards and test methods and how they relate to Abbott product. Facilitates a systems-level approach to Product Safety compliance for new product development and design changes to existing product.Working knowledge of test set up and execution as required per UL/CSA/IEC 61010-1 and 61010-2-101 and other 61010 particulars as applicable. Provides guidance to test technicians and junior engineers on Product Safety test setup, execution and troubleshooting.Actively participates in UL witness testing with UL engineers for changes to existing product and new product launches.Conduct quarterly UL audits for Abbott manufactured product and ISO 17025, addresses any variation notices.Performs basic EMC/Safety assessments for design changes to existing product, providing design recommendations to R&D engineers and management. Regularly communicates directly with UL/EU Notified Body on design changesCreates/updates IEC 60825-1 and CDRH laser reports according to Form FDA 3632.Perform regulatory impact assessments for new product standards and/or changes to existing standards affecting Abbott products.Major Responsibilities/KnowledgeHands-on technical knowledge and expertise of Product Safety test methods and test equipment, procedures, and standards.Completes professional level engineering assignments related to Product Safety. Leads and participates in projects involving the design, fabrication, and manufacture of complex instrument subassemblies, systems or processes.Collaborates across functional areas, including engineering, project management and other systems development personnel.Maintains test capability by researching required test equipment to align with regulatory changes and/or product changes/enhancements.Creates and/or maintains internal test procedures according to associated external test method standards, directives and regulations.Responsible for implementing and maintaining the effectiveness of the quality system.Maintains lab areas in a state of audit readiness, following cGMP practices. Assists with metrology requirements for equipment calibration and OOT assessments.Consistently meets timelines for the completion of Product Safety related activity in support of program timelines.Strong organizational skill, follow-up and attention to detail. Strong written and verbal communication skills.Travel as necessary to aid in program facilitation or for training (5%)Basic Qualifications:Bachelor's degree in an engineering or closely related discipline with 6+ years progressive work experience in laboratory environment, field service, Safety and/or with Abbott Diagnostics products.Preferred Qualifications: Bachelor’s Degree in Electrical, Mechanical, or Biomedical Engineering with a minimum of 6+ years work experience in Medical Device Product Safety testing.