Safety Engineer

Abbott • Irving, TX

16d • Onsite

About The Position

Abbott’s Core Lab business is hiring a Product Safety Engineer for its Irving, Texas office. The role provides engineering leadership and expertise in support of new and existing products, processes, prototypes, fixtures, and tools. It applies engineering and scientific principles to evaluate and solve technical problems, with a focus on product safety compliance, testing, and laboratory readiness. The position works across engineering, project management, and systems development teams and supports products used in healthcare diagnostics.

Requirements

• At least 3 years of relevant experience.
• Engineering experience in product or process development and technical design.
• Bachelor’s degree in engineering or a closely related discipline.
• Ability to apply statistics and analytical thinking.
• Technical knowledge and expertise in subsystems, design protocols, and problem-solving tools.
• Effective time management and prioritization skills.
• Strong written and verbal communication skills.
• Demonstrated ability to work in a team environment.
• Strong organizational skills, follow-up, and attention to detail.

Nice To Haves

• Bachelor’s degree in Electrical, Mechanical, or Biomedical Engineering, with at least 2 years of work experience in Medical Device Product Safety testing.
• At least 1 year of progressive work experience in a laboratory environment, field service, Safety, and/or with Abbott Diagnostics products.
• Test laboratory experience.
• Hands-on technical knowledge and expertise in Product Safety test methods, test equipment, procedures, and standards.

Responsibilities

• Facilitate a systems-level approach to Product Safety compliance for new product development and design changes to existing products.
• Set up and execute tests as required under UL/CSA/IEC 61010-1, 61010-2-101, and other applicable 61010 particulars.
• Participate in UL witness testing for changes to existing products and new product launches.
• Conduct quarterly UL audits for Abbott-manufactured products and ISO 17025, and address variation notices.
• Communicate directly with UL/NRTL regarding design changes.
• Create and update IEC 60825-1/62471-1 and CDRH laser reports.
• Complete professional-level engineering assignments related to Product Safety.
• Lead and participate in projects involving the design, fabrication, and manufacture of complex instrument subassemblies, systems, or processes.
• Collaborate with engineering, project management, and other systems development personnel.
• Research test equipment needs to maintain test capability in response to regulatory or product changes and enhancements.
• Create and maintain internal test procedures aligned with external test-method standards, directives, and regulations.
• Implement and maintain the effectiveness of the quality system.
• Maintain laboratory areas in an audit-ready state and follow cGMP practices.
• Assist with equipment calibration and out-of-tolerance (OOT) assessments for metrology requirements.
• Complete Product Safety activities on schedule in support of program timelines.
• Travel as necessary to support program facilitation or training; travel is approximately 5%.
• Perform basic EMC/Safety assessments for design changes to existing products and provide design recommendations to R&D engineers and management.

Benefits

• Career development opportunities with an international company.
• Eligible employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level