Software Development Quality Engineer

Abbott

Plano, Texas, United States
Base: $68,000.00 – $136,000.00; bonus/equity: not ...
Onsite
Software quality assurance
Medical device regulations
Iec 62304 software lifecycle
Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with design control requirements and patient safety objectives

Job Summary

  • Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with design control requirements and patient safety objectives.
  • Provide quality engineering oversight for AI/ML-enabled software features, evaluating risk controls and ensuring traceability between hazards, requirements, and mitigation evidence.
  • Champion continuous improvement in software quality processes, contributing to updates of risk management processes, design control workflows, and software validation best practices.

Matching Summary

Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with design control requirements and patient safety objectives.

Salary

Base: $68,000.00 – $136,000.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Software quality assurance
  • Medical device regulations
  • IEC 62304 software lifecycle
  • ISO 14971 risk management
  • FDA 21 CFR Part 820 compliance

Nice-to-have

  • AI/ML software oversight
  • Cybersecurity requirements knowledge
  • Cross-functional collaboration
  • Continuous improvement champion

Key Requirements

  • Bachelor's degree in technical discipline
  • Minimum 2 years software quality experience
  • Experience with regulated industry
  • Understanding of medical device regulations

Work Rights

Not specified

Tailored Resume

Cover Letter