Base: $86,700.00 – $173,300.00; bonus/equity: not ...
Onsite
Software development life cycle processes
Verification and validation practices
Risk-based quality engineering
Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with global regulations and standards
Job Summary
Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with global regulations and standards.
Provide quality engineering oversight for AI/ML-enabled software features, evaluating risk controls and ensuring traceability between hazards, requirements, and mitigations.
Abbott offers career development, excellent benefits including medical coverage and retirement savings, and is recognized as a great place to work globally.
Matching Summary
Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with global regulations and standards.
Salary
Base: $86,700.00 – $173,300.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
Software development life cycle processes
Verification and validation practices
Risk-based quality engineering
Medical device regulatory frameworks
FDA QSR design control requirements
IEC 62304 software lifecycle processes
ISO 14971 risk management activities
Nice-to-have
AI/ML enabled software features oversight
Cybersecurity requirements understanding
Cross-functional collaboration skills
Continuous improvement champion
Data-driven problem solving
Key Requirements
Bachelor’s degree in Computer Science/Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline
8+ years of software quality or design quality experience in a regulated industry
Strong understanding of IEC 62304, ISO 14971, ISO 13485, and/or FDA 21 CFR Part 820
Experience with implantable Class III medical devices or safety-critical embedded systems (preferred)
Experience with AI/ML development (highly preferred)