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.
Job Description
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.

THE OPPORTUNITY

This position works out of our SYLMAR, CA location in the CARDIAC RHYTHM MANAGEMENT division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
We are seeking a high caliber SOFTWARE QUALITY ENGINEER I. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. Applies engineering and scientific principles to the evaluation and solution of technical problems in a creative manner unique to each project. Exercises level appropriate technical judgment in planning, organizing, performing, and/or coordinating engineering work.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree OR an equivalent combination of education and work experience Experience/Background Experience Experience Details
• Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.
• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices Preferred.
• Knowledge of ISO 13485 standard. Knowledge of quality management techniques and application.
• Ability to clearly, concisely and accurately convey communications. Ability to form and develop interpersonal, professional relationships. Display socially and professionally appropriate behavior. Ability to work independently and in groups. Ability to work cross-functionally. Demonstrated initiative and problem-solving skills. Critical-thinking skills. Ability or aptitude to use various types of databases and other computer software. Strong organizational skills. Ability to prioritize. Ability to multitask. Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives. Ability to quickly gain knowledge, understanding or skills and is willing to learn.

PREFERRED QUALIFICATIONS :

• Electrical/Computer Engineering
• Software Quality Engineering experience
• Prior medical device experience preferred.
• Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
• Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred.
• Programming experience in C/C++/C#, Scripting Language such as Python.
• Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
• Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills.

• Work with R&D in the completion of system/software requirements and other verification and validation processes related to embedded software products.
• Participate in reviews for Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.
• Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans, test scripts (manual and automated), test reports.
• Identifies parameters, structure, and critical test components. Writes, updates, or executes test design, cases, as well as procedures and reports results.
• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
• Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks.
• Follow approved Design Control procedures for software development in accordance with FDA guidelines.
• Contributes to and supports root-cause analysis of failures. Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
• Support internal (corporate and divisional) and external quality audit.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Readily adjusts priorities and works within team environment for timely completion of common objectives for multiple projects.
• 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.