Software Development Quality Engineer

Abbott

Plano, TX, 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

Job Summary

  • Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices.
  • Ensure compliance with IEC 62304 software lifecycle processes, including software safety classification, and system and software level verification.
  • Champion continuous improvement in software quality processes, contribute 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.

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
  • Design control compliance

Nice-to-have

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

Key Requirements

  • Bachelor's degree in Computer Science/Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline
  • Minimum 2 years of software quality or design quality experience in a regulated industry
  • Understanding of medical device regulatory frameworks
  • Strong analytical/problem solving skills

Work Rights

Not specified

Tailored Resume

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