Senior Compliance Software Engineer (Product)

About the position

The Senior Compliance Software Engineer (Product) will be responsible for participating as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products. This role ensures that digital applications and firmware produced by Abbott Diabetes Care are developed, validated, and maintained in compliance with regulatory, corporate, and divisional requirements. The engineer will review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software, and coordinate activities with other engineering disciplines, departments, and contractors.

Responsibilities

• Completes software quality tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager.
• Plans and coordinates own work according to higher-level project schedules.
• Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans.
• Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Assists subordinate staff in recognizing unexpected events, issues or software bugs.
• Coordinates the development and maintenance of departmental operating procedures to ensure compliance with relevant FDA, QSR, ISO guidelines.
• Acts as Software Quality lead in various phases of the development lifecycle.
• Maintains schedule and drives to meet project schedule aligned with project goals.
• Estimates, plans, schedules and reviews own and others’ work products.

Requirements

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• 5 to 8 years’ experience in Software Quality Assurance and/or Software Testing experience.
• Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11.
• Knowledge of Design Control requirements.
• 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices.
• Excellent oral and written communication skills.

Nice-to-haves

• ASQ Certifications.
• Experience in working in a regulated environment.
• Familiarity with Cybersecurity, AI, and cloud computing.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and the Freedom 2 Save student debt program.
• FreeU education benefit for an affordable path to getting a bachelor’s degree.