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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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.

· Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

· An excellent retirement savings plan with a 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 worldwide 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 Core Lab business currently has an opportunity for a Product 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.

The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

What You’ll Work On

• Experience 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 products.
• Working knowledge of test setup and execution as required per UL/CSA/IEC 61010-1 and 61010-2-101 and other 61010 particulars as applicable.
• 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, addressing any variation notices.
• Regularly communicates directly with UL/NRTL on design changes
• Creates/updates IEC 60825-1/62471-1 and CDRH laser reports.

• 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%)

Required Qualifications

• Minimum 3 years Relevant Experience Engineering experience in product / 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 of subsystems, design protocols, and problem-solving tools.
• Ability to apply statistics and analytical thinking.
• Effective time management and prioritization skills.
• Strong written & verbal communication skills
• Demonstrated experience working in a team environment.

Preferred Qualifications

• Bachelor’s degree in electrical, Mechanical, or Biomedical Engineering with a minimum of 2+ years of work experience in Medical Device Product Safety testing.
• One (1) + years of progressive work experience in a laboratory environment, field service, Safety, and/or with Abbott Diagnostics products.
• Test Laboratory experience.
• Performs basic EMC/Safety assessments for design changes to existing products, providing design recommendations to R&D engineers and management.

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