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 114,000 colleagues serve people in more than 160 countries.

THE OPPORTUNITY

Our Irving, TX location is looking for a Sr. Software Design Quality Engineer. This person will be responsible to review and participate in all aspects of product design control for On-Market and In-Development activity in the Medical Device space. It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to software product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Computer Science, Software Biomedical Engineering; Life Science or closely related discipline is required. Master’s degree preferred.
• Minimum 4 years of related work experience in quality or a related field

PREFERRED QUALIFICATIONS

• 5+ years’ experience covering the entire design control process in a team-oriented environment.
• Prefer tool experience with HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS.
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, 21 CFR Part 11 and IEC 62304 Medical Device Software – Software life cycle processes.
• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices is a plus.
  Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.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.
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  The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted

Please refer the Job description for details