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
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
- 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.
JOB FAMILY
Operations Quality
DIVISION
CRM Cardiac Rhythm Management
LOCATION
United States > Sylmar : 13150 Telfair Avenue
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
