Principal Software Design Quality Engineer, Cybersecurity

at Abbott Laboratories
Published May 5, 2021
Location Irving, TX
Category Default  
Job Type Full-time  

Description

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 109,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS:

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.

Our location in Irving, TX, currently has an opportunity for Principal Software Design Quality Engineer, Cybersecurty

WHAT YOU’LL DO

Primary function is to review and participate in all aspects of product design control for On-Market and In-Development activity as it relates to software & cybersecurity.  It is expected to have a firm understanding of cybersecurity best practices & tools comprehending the identification, analysis, mitigation, tracking and controlling of cybersecurity risks 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.  This position will be required to provide support for Site, Division & Corporate cybersecurity initiatives & continued On-Market Surveillance.  

Responsible for implementing and maintaining the effectiveness of the quality system.

  • Cybersecurity – Understands and applies basic cybersecurity principles.

    Maintains awareness of cybersecurity regulations & changes and facilitates needed updates to the associated software processes.

    Promotes cybersecurity principles & testing in all aspects of software development.

    Understands cybersecurity vulnerabilities and threat scenarios as it applies to the Cybersecurity Risk Analysis Report.

    Interacts with corporate process teams to support continued development of a risk-based cybersecurity program.

  • Design/Change Control – Software responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.

  • Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.  Understands cybersecurity vulnerabilities and threat scenarios as it applies to the Cybersecurity Risk Analysis Report.

  • 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.

Accountability/Scope: 

Ability to work effectively within a team in a dynamic & fast paced environment. Ability to work on numerous projects in parallel. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Anticipates the impact and risk of decisions and actions at both the project and organizational level.  Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required Skills/Knowledge/Experience:

  • Bachelor’s Degree in Engineering or technical discipline or equivalent experience plus demonstrated competence

  • 5+ years applicable engineering experience in software development, medical device or instrument realization, project management or related field and 5+ years’ experience in design control, qualification, FMEA, specification and risk mitigation.

Preferred

  • B.S. in Computer Science; Software Engineering; Information Security; Biomedical Engineering; MS is preferred.  

  • 10+ years’ experience covering the entire design control / cybersecurity process in a team-oriented environment.

  • Detailed knowledge of FDA (including 21 CFR Part 11), GMP, IEEE 1012 and ISO 13485

  • CISSP certification (or similar) and be knowledge of national and international regulatory compliances and frameworks such as ISO, SOX, BASEL II, EU DPD, HIPAA, and PCI DSS. 

  • Prefer tool experience with HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS. 

  • Knowledgeable of FDA 21 CFR Part 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines, IEC 62304, FDA 21 CFR Part 11, FDA Pre-Market & Post-Market Cybersecurity Guidance and international cybersecurity regulations/guidance such as IMDRF.

  • Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices is a plus.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the 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 on Twitter @AbbottNews and @AbbottGlobal.