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.
Hands-on technical knowledge and expertise in Product Safety test methods and test equipment, procedures, and standards.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
- 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.
JOB FAMILY
Product Development
DIVISION
CRLB Core Lab
LOCATION
United States > Irving : LC-02
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
No
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
