Senior Safety Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation, and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices, and clinics.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save (~~~) student debt program, and FreeU (~~~) education benefit - an affordable and convenient path to getting a bachelor's degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our Diagnostics business currently has an opportunity for a Senior Safety Engineer for our Irving, Texas office. The primary function of this position is to provide engineering leadership and expertise to support new and existing products, processes, prototypes, fixtures, and tools. Applies engineering and scientific principles to the evaluation and solution of technical problems.

What You'll Work On

• Expertise with Safety concepts, standards, and test methods and how they relate to Abbott products.

• Facilitates a systems-level approach to Product Safety compliance for new product development and design changes to existing product.

• Demonstrated proficiency with test setup 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 products and new product launches.

• Conduct quarterly UL audits for Abbott manufactured products and ISO 17025, and address any variation notices.

• Performs EMC/Safety assessments of moderate complexity design changes to existing products, providing design recommendations to R&D engineers and management.

• Creates/updates IEC 60825-1 and CDRH laser reports according to Form FDA 3632.

• Creates/updates Safety technical files for CE marking.

• Interact with Abbott Regulatory Affairs as needed to support new product registrations.

• Perform regulatory impact assessments for new product standards and/or changes to existing standards affecting Abbott products.

• 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 skills, follow-up, and attention to detail. Strong written and verbal communication skills.

• Travel as necessary to aid in program facilitation or for training (5%).

EDUCATION AND EXPERIENCE YOU'LL BRING

Minimum Qualifications

• Bachelor's degree in engineering or closely related discipline with 7+ years of progressive work experience in a 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 7+ years of work experience in Medical Device Product Safety testing.

Learn more about our benefits that add real value to your life to help you live fully: ~~~ . Follow your career aspirations to Abbott for diverse opportunities with a company that provides growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ~~~ , on Facebook at ~~~/Abbott , and Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $83,000.00 - $166,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call ~~~ or email ~~~