Abbott is seeking a Software Quality Engineer to ensure software systems are developed, validated, and maintained in compliance with regulatory and business procedures, specifically for non-product software in the Cardiac Rhythm Technologies division.
Requirements
- Bachelor’s Degree in Engineering or Technical Field (Electrical/Computer Engineering preferred) or an equivalent combination of education and work experience.
- Minimum 2 years roles of Software Quality Engineering experience
- Industry certification preferred.
- Class III or II medical device experience.
- Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.
- Knowledge of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485.
- Programming experience in C/C++/C, Scripting Language such as Python.
Responsibilities
- Provide guidance and training to the site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.
- Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
- Create and execute or direct software validation protocols traceable to system/software requirements.
- 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.
- Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
Other
- 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 and critical-thinking skills.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
