Senior Software Quality & Risk Assurance Engineer

Thornton Tomasetti; Burlington (VT); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Career development

Free HIP PPO medical coverage

Tuition reimbursement

Freedom 2 Save student debt program

FreeU education benefit

Job summary

Abbott is seeking a Senior Software Design Assurance Engineer to support software quality activities across the product development lifecycle. You will ensure compliance with design controls, oversee verification/validation, and collaborate with R&D and other functional teams.

The role focuses on software quality but also supports broader product development, with opportunities to influence quality systems, risk management, and cybersecurity considerations in a global healthcare environment.

Qualifications

• Bachelor’s degree in engineering or a technical field.
• Minimum of 5 years related work experience in Quality or a related field.
• Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Responsibilities

• Provide technical and quality system guidance for software requirements.
• Oversee software verification and validation activities for new products per design planning procedures.
• Review and approve software test case protocols, reports, and development plans.
• Lead meetings to prioritize action plans for issues identified in problem resolution systems.
• Lead risk evaluation and management activities related to software development, incl. risk analyses.

Skills

Verbal and written communication

Cross-functional collaboration

Quality engineering principles

Education

Bachelor’s degree in engineering or technical field

Advanced degree

Job description

Abbott is seeking a Senior Software Design Assurance Engineer to support software quality activities across the product development lifecycle. You will ensure compliance with design controls, oversee verification/validation, and collaborate with R&D and other functional teams.

The role focuses on software quality but also supports broader product development, with opportunities to influence quality systems, risk management, and cybersecurity considerations in a global healthcare environment.