Cybersecurity-Focused Software Quality Engineer (Med Device)

Abbott; Massachusetts; On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott seeks a Software Quality Engineer for Cybersecurity Compliance in Westford, MA. You will support software quality and cybersecurity activities, review risk, maintain design controls, and collaborate with Product Development, Quality, and Cybersecurity teams to ensure regulatory compliance.

The role is fully onsite in Abbott Vascular and requires experience with SDLC, audits, and CAPA, plus knowledge of FDA/IEC standards. Competitive base pay and benefits accompany this opportunity.

Qualifications

• Bachelor-level degree in Computer science, biomedical engineering, software engineering or related field.
• 2–5 years in software quality engineering, software validation, or cybersecurity quality/compliance.
• Experience with design controls for Class II medical devices.

Responsibilities

• Support quality engineering deliverables throughout product lifecycle, including risk management and cybersecurity risk.
• Ensure on-time execution of Quality Plans and development of SOPs, specs, and test procedures.
• Review test methods, protocols and results from other groups and support change management.

Skills

Agile SDLC

Cross-functional teamwork

Regulatory awareness

Detail-oriented

Education

Bachelor's degree in Computer Science / software engineering / biomedical engineering

Equivalent work experience

Tools

Jira

Jama

TestComplete

Coverity (static analysis)

Job description

Abbott seeks a Software Quality Engineer for Cybersecurity Compliance in Westford, MA. You will support software quality and cybersecurity activities, review risk, maintain design controls, and collaborate with Product Development, Quality, and Cybersecurity teams to ensure regulatory compliance.

The role is fully onsite in Abbott Vascular and requires experience with SDLC, audits, and CAPA, plus knowledge of FDA/IEC standards. Competitive base pay and benefits accompany this opportunity.