Software Quality Engineer I

MAIN PURPOSE OF ROLE

This is an ONSITE role based out of Sylmar, CA

The Software Quality Engineer I provides design quality engineering support for the development and maintenance of mobile medical device software applications and connected digital health solutions. This role partners closely with software development, systems engineering, cybersecurity, product management, clinical, and regulatory teams to ensure software products are developed in accordance with applicable quality system regulations, industry standards, and company procedures. The position will primarily support native mobile applications (iOS and Android), cloud-connected healthcare solutions, and related software systems.

What You’ll Do

• Support design quality activities throughout the software development lifecycle, including requirements reviews, risk management, software verification and validation, traceability assessment, cybersecurity assessments and defect management.
• Review software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes.
• Support software risk management activities in accordance with ISO 14971 and internal procedures.
• Evaluate software defects and assess potential product quality impacts.
• Participate in investigation and resolution of software-related quality issues.
• Gain familiarity with testing methodology, processes, tools, templates, environment, and work with cross functional teams to complete tasks assigned
• Review system, integration, regression, usability, and mobile application testing verification strategies, protocols, reports, and test evidence. Review test coverage to ensure adequate verification of requirements and risk controls.
• Complete Document Change Request Reviews in a timely and objective manner
• Drive continuous improvement activities and support investigations, CAPAs, and compliance initiatives related to software products and processes.
• Support preparation and maintenance of Design History File (DHF) and software lifecycle documentation.
• Support internal & external audit and related responses
• 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.

Education And Experience You’ll Bring

• Bachelor level degree in Computer science, software engineering or a closely related discipline or an equivalent combination of education and work experience.
• Minimum 2-5+ years of combined experience in software quality, software development, software verification and validation, software testing, or related engineering role.
• Understanding of software development lifecycle methodologies including Agile development practices.
• Fundamental understanding of software engineering principles and quality systems.
• Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl
• Experience with software configuration, and issue tracking tools such as GIT, Jira, Azure DevOps, ClearQuest, DOORS.
• Experience with test automation and analysis tools such as Selenium, Appium, Postman, API testing tools.
• Strong analytical and problem-solving skills.
• 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.

Preferred Experience

• Experience supporting development and deployment of mobile applications for iOS and Android platforms.
• Experience working in a regulated industry such as medical devices, healthcare, pharmaceuticals, aerospace, or automotive.
• Familiarity with medical device software standards including : IEC 62304, ISO 14971, IEC 62366, IEC 82304-1, FDA Quality System requirements
• Knowledge of mobile application architecture and development concepts.
• Experience reviewing software requirements, test protocols, and design documentation.
• Familiarity with software defect tracking and requirements management tools.
• Experience with cloud-connected, distributed, or client-server software systems.
• Understanding of cybersecurity principles and secure software development practices.

Apply Now

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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 $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.