Abbott Senior Software Development Quality Engineer in Sylmar, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The Senior Software Design Quality Engineer is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Job Duties:

  • Execute and support on-time completion of Design Control Deliverables

  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

  • Guides development and documentation of standard operating procedures, specifications and test procedures

  • Guide peer engineers with understanding of the system knowledge and effectively writing up of the use cases.

  • Coach and mentor team members on best practices in verification and validation testing to establish product and system reliability

  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

  • Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection.

  • Reviews test protocols and test results provided by another functional group.

  • Lead or support Risk Management activities from product Concept through Commercialization

  • Bring forth ideas and implement quality tools that improve the software design reviews

  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

  • Provide guidance to Threat Modeling to identify threats and security risks for the system, and implement quality procedure based on Threat Model of Cyber attacks

  • Support internal & external audit and related responses

  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements

  • Complete Document Change Request Reviews in a timely and objective manner

  • Additional duties may be identified by functional management based on the current project/business objectives.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Performs other related duties and responsibilities, on occasion, as assigned.

General Qualifications

  • Bachelor level degree in Engineering or Technical Field, advanced degree preferred.

  • 3-5 years experience in software development in either Mobile Application (iOS, Android), Web Based Application, or Medical device

  • 7-9 years experience in software testing and validation, including lead or supervisory experience

  • Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl

  • Working experience in behavior driven testing and scripting using cucumber or behave.

  • Working experience in behavior driven tesing for Mobile Application using Calabash

  • Experience with Cybersecurity Risk Management activities; such as Threat Modeling, writing Quality Procedure to validate the design mitigations

  • Previous Software Quality engineering experience and demonstrated use of Quality tools/methodologies

  • Experience with software configuration, and issue tracking tools such as GIT, Subversion, ClearQuest, Doors, TortoiseHg, or Bugzilla.

  • Experience in review tool(s) to aide code review such as Code Collaborator.

  • Experience working in a broader enterprise/cross-division business unit model preferred.

  • Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multitasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational and follow-up skills, as well as attention to detail.

  • Ability to travel

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