Safety Engineer

About the Role

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.

Responsibilities

• 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.

Qualifications

• Minimum 3 years of relevant experience in engineering, 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.
• Effective time management and prioritization skills.
• Strong written and 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.
• Hands-on technical knowledge and expertise in Product Safety test methods, test equipment, procedures, and standards.

Benefits

• 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.

Pay

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/