Senior Medical Device Software Systems Engineer

Biopharma Careers; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott in Pleasanton, CA, seeks a Senior Software Systems Engineer to design, develop, and test complex software for medical devices and connected health platforms, translating customer and stakeholder needs into actionable specifications.

You will lead cross-functional teams, drive requirements traceability, risk management, and verification plans, and ensure regulatory compliance across the development lifecycle.

Qualifications

• Bachelor's degree in software engineering, computer science, or a related engineering field.
• 8+ yrs relevant experience and a BS degree, or 6 yrs relevant experience and a MS degree, or equivalent years of education and experience in Engineering and Sciences.

Responsibilities

• Leads complex digital health programs spanning cloud platforms, mobile apps, connected devices, data pipelines, and clinical workflows.
• Drives standardized engineering methods and processes that improve design rigor and cross-functional team alignment.
• Leads structured execution of digital product development, translating ambiguous business and clinical inputs into well-defined plans and actionable requirements.
• Plans and executes department strategy to deliver responsibilities, frames problems, and tracks progress within scope.
• Partners with internal stakeholders to define product vision and high-level requirements, then decomposes them into detailed software requirements.
• Contributes to risk management activities, conducts hazard analysis, and ensures risk controls are translated into requirements and tests.
• Drive design reviews and enforce best practices for requirements traceability, validation, and compliance throughout the lifecycle.
• Organizes and manages work to deliver programs and leads execution; collaborates across teams to resolve issues.

Skills

Software engineering

Regulatory compliance

Requirements management

Cloud platforms (AWS/Azure/GCP)

Medical device knowledge

Education

Bachelor's degree in software engineering, computer science, or a related engineering field

Tools

DOORS

JIRA

Job description

Abbott in Pleasanton, CA, seeks a Senior Software Systems Engineer to design, develop, and test complex software for medical devices and connected health platforms, translating customer and stakeholder needs into actionable specifications.

You will lead cross-functional teams, drive requirements traceability, risk management, and verification plans, and ensure regulatory compliance across the development lifecycle.