Safety Engineer

Primary Job Function: Safety Engineer

• 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 changes
• Creates/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/Knowledge

• Hands-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%)