Senior Software Quality Assurance Engineer Medical Devices

Regulatory Jobs; Burlington (MA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage (HIP)

Retirement savings plan

Tuition reimbursement

Education benefit (FreeU)

Student debt program

Diversity and inclusion programs

Job summary

Abbott is seeking a Senior Software Design Assurance Engineer to support product development and maintain software quality engineering methodologies. This role focuses on software quality but may support other product development aspects based on experience.

Responsibilities include guiding software requirements, overseeing verification/validation, leading risk assessments, and ensuring compliance with FDA and other regulatory requirements.

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

• Provides technical and quality system guides related to establishing software requirements.
• Quality oversight for software verification and validation activities for new products.
• Leads meetings to prioritize and address issues in problem resolution systems during development.
• Leads risk evaluation and mitigation of software issues (e.g., FMEA, risk analysis).
• Participates in technical and management reviews to ensure design outputs meet requirements.
• Provide quality oversight for non-product software validation and related documentation.
• May assist with cybersecurity assessments with cross-functional team.
• Complies with FDA/regulatory requirements and company policies.
• Maintains cross-functional partnerships, especially with R&D.
• Works as individual contributor or mentor to QE team.
• Develops and conducts training for divisional software development/validation.
• Supports audits and drives quality system improvement activities.

Skills

Quality engineering

Regulatory knowledge

Software quality assurance

Communication skills

Education

Bachelor’s degree in engineering or technical field

Advanced degree

Job description

Abbott is seeking a Senior Software Design Assurance Engineer to support product development and maintain software quality engineering methodologies. This role focuses on software quality but may support other product development aspects based on experience.

Responsibilities include guiding software requirements, overseeing verification/validation, leading risk assessments, and ensuring compliance with FDA and other regulatory requirements.