Software Test Engineer

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 –Software Test Engineer

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our Diabetes division in Alameda, CA, currently has an opportunity for a Software Test Engineer to perform computer system validation on applications and tools developed. Position requires coming into the office five days a week.

WHAT YOU’LL DO

• Manage validation projects, including developing project plans, coordinating resources, and tracking progress.
• You will be responsible for developing and executing validation plans, protocols, and test cases to ensure that computer systems meet the validation procedures.
• You will be responsible for documenting all validation activities, including test results, deviations, and corrective actions. This documentation is used to demonstrate compliance with site procedures.
• You will collaborate with cross-functional teams, including IT, quality assurance, R&D, to ensure that computer systems are validated and compliant with site procedures.
• You must have a deep understanding of computer systems, software validation methodologies, in a regulated environment. You must be able to provide technical expertise to ensure that

computer systems are validated properly.

• Follows operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines,

including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC software/firmware products.

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• 5 – 7 years’ experience in Software Testing and/or Software Quality Assurance, and at least 2 of them validating computer systems.
• 2 years’ experience working in a regulated environment
• Must be technically strong and have experience validating computer systems
• Must have excellent oral and written communication skills.

• Experience with Software Quality Assurance. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. In particular, has knowledge of Design Control requirements. Must have 2 - 4 years project experience in Software Testing practices, methodologies and techniques, preferably in testing medical devices.

Preferred

• Medical Device industry experience strongly preferred.

The base pay for this position is $95,500.00 – $190,900.00. In specific locations, the pay range may vary from the range posted.