Software Design Assurance Engineer

BD

San Diego, CA, USA
Base: $102,000.00 - $168,200.00 usd annual; bonus/...
Fully remote
Iso 13485 compliance knowledge
Iec 62304 software lifecycle expertise
Iso 14971 risk management application
This role ensures compliance with global medical device quality system regulations including ISO 13485, IEC 62304, and ISO 14971

Job Summary

  • This role ensures compliance with global medical device quality system regulations including ISO 13485, IEC 62304, and ISO 14971.
  • The engineer will develop and execute test plans while integrating cybersecurity controls to validate secure coding standards.
  • Candidates must possess a Bachelor's degree and 3-5 years of experience in a collaborative environment requiring four days of in-office presence weekly.

Matching Summary

This role ensures compliance with global medical device quality system regulations including ISO 13485, IEC 62304, and ISO 14971.

Salary

Base: $102,000.00 - $168,200.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package with rewards and recognition programs

Skills & Requirements

Must-have

  • ISO 13485 compliance knowledge
  • IEC 62304 software lifecycle expertise
  • ISO 14971 risk management application
  • Secure SDLC process alignment
  • Functional and regression testing execution

Nice-to-have

  • Cybersecurity vulnerability remediation experience
  • Cross-functional collaboration skills
  • Root-cause analysis proficiency
  • Continuous improvement mindset
  • Architecture and design review participation

Key Requirements

  • Bachelor's Degree in Computer Science, Risk Management, or Quality Assurance
  • 3-5 years of relevant professional experience
  • Minimum 4 days per week in-office attendance required

Work Rights

Not specified

Tailored Resume

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