Software Design Assurance Engineer

BD (Becton, Dickinson, and Company)

San Diego, CA, USA
Base: $102,000.00 - $168,200.00; bonus/equity: not...
Fully remote
Iso 13485 compliance knowledge
Iec 62304 software lifecycle expertise
Iso 14971 risk management application
The role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971

Job Summary

  • The role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971.
  • Candidates will partner with Quality Assurance, Compliance, and Engineering teams to align processes with secure SDLC expectations.
  • The position requires a minimum of 4 days of in-office presence per week to foster creativity and innovation.

Matching Summary

The role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971.

Salary

Base: $102,000.00 - $168,200.00; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards

Skills & Requirements

Must-have

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

Nice-to-have

  • Cybersecurity vulnerability remediation skills
  • Cross-functional collaboration experience
  • Root-cause analysis proficiency
  • Process improvement mindset
  • Defect tracking best practices

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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