Staff Engineer, Design Assurance- Software

Abbott

Pleasanton, CA, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
Onsite
Software design assurance lead
Medical device software development lifecycle
Risk management per iso 14971
This position ensures medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards, serving as the software design assurance lead for complex, safety-critical systems

Job Summary

  • This position ensures medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards, serving as the software design assurance lead for complex, safety-critical systems.
  • You will embed with R&D as the quality core-team representative to ensure design controls, risk management, cybersecurity, and verification/validation are planned and executed to deliver safe, effective Class III medical devices worldwide.
  • Abbott offers career development with an international company, access to free medical coverage, an excellent retirement savings plan, tuition reimbursement, and is recognized as a great place to work globally.

Matching Summary

This position ensures medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards, serving as the software design assurance lead for complex, safety-critical systems.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Software Design Assurance Lead
  • Medical Device Software Development Lifecycle
  • Risk Management per ISO 14971
  • Software Verification and Validation
  • Cybersecurity for Medical Devices
  • FDA 21 CFR Part 820
  • EU MDR 2017/745

Nice-to-have

  • Strategic quality leadership
  • Mentoring mindset
  • Cross-functional leadership
  • Calm, fact-based execution
  • Influencing design strategy

Key Requirements

  • Bachelor's degree in technical discipline
  • 8 years Software Development and Design Quality Engineering experience
  • Knowledge of FDA, ISO 13485, ISO 14971, IEC 62304
  • Experience with medical device software for Cloud/mobile

Work Rights

Not specified

Tailored Resume

Cover Letter