Software Quality Engineer II at Abbott

Sylmar, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

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 of Software Quality Engineering experience
Industry certification preferred
Class III or II medical device experience
3-5 years of relevant experience

Responsibilities

Provide guidance and training to site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance
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
Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports
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
Support internal (corporate and divisional) and external quality audits
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Skills

Quality Engineering

Software Validation

Regulatory Compliance

Quality Methodologies

Software Testing

Medical Devices Software

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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