Job Information
Abbott Sr Software Design Quality Engineer in Irving, Texas
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.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are 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.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 high employer contribution
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 a best place to work for diversity, working mothers, female executives, and scientists.
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.
What You’ll Work On
Responsible for implementing and maintaining the effectiveness of the quality system.
Design/Change Control - Software responsibilities include participating in the planning, development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
Collaboration with On-Market & Development TeamsWorks closely with software developers, product managers, and other stakeholders to understand technical requirements, provide input on design considerations, and participate in discussions about software functionality. Key collaboration topics are the following:
Software / Firmware Skills - Applies basic software knowledge, including understanding of firmware basics, Run time operating systems, Operating systems (Linux, MS Windows, etc.) and application basics (install, running, etc.).
Basic Network Functionality - Applies basic network understanding for the three kinds of networking utilized in our systems (Ethernet, CAN bus, and Near Field Communication (NFC).
Cybersecurity - Understands and applies basic Cybersecurity control measures, Familiarity with the Cybersecurity workbook, Threat Modeling, vulnerability assessment and the Cybersecurity Risk Analysis Report.
SOUP/OTS Software - Applies basic understanding of SOUP & OTS components and the applicable governing standards.
Software Lifecycle Process - Applies basic understanding of the planning, development, modification and maintenance of software.
Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc. Provides guidance on software safety classifications.
Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records. Provides guidance on developing and implementing software test strategies & methodologies.
Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Quality Engineering – Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of 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 (http://www.abbottbenefits.com/pages/candidate.aspx)
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 www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com