Senior Safety Engineer - (Laboratory Test Engineer) Job
Job Description Job Attributes+
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Job ID
31091426
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Req #
ABLAUS31091426ENUSEXTERNAL
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Job Location
Irving, TX, US
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Job Category
Research & Development
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Job Type
Full time
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Travel
Yes, 5 % of the Time
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Schedule
40 hours per week
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 forour 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
- 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.
- 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, addressing any variation notices.
- 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.
- 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%)
EDUCATION AND EXPERIENCE YOU’LL BRING:
Required Qualifications and Experience:
- Bachelor's degree in engineering or a closely related discipline.
- Six (6) + 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 and test equipment, procedures, and standards.
Preferred Qualifications
- Bachelor’s degree in electrical, Mechanical, or Biomedical Engineering with a minimum of 6+ 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: http://www.abbottbenefits.com/pages/candidate.aspx. 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 www.abbott.com, on Facebook at www.facebook.com/Abbott, and Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.
Job Skills
- biomedical engineering
- product development
- program facilitation assistance
- test procedures
- product safety
- fda reporting skills
- iso 17025
- product safety engineering
- project management
- technical problem-solving
- product safety guidance
- ul testing participation
- audit readyness maintenance
- time management
- regulatory impact assessment
- equipment calibration assistance
- test equipment
- cgmp practices
- troubleshooting
- engineering leadership
- metrology
- iec 61010
- regulatory compliance research
- test laboratory
Additional Information
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.
