Software Design Quality Engineer Ii

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $92,000.00 - $148,350.00; bonus/equity: long...
Hybrid
Bachelor's degree in engineering or science
2 years related work experience
Iec 62304 compliance knowledge
The role supports New Product Development and sustaining activities while managing product risk, cybersecurity, and design controls for medical devices

Job Summary

  • The role supports New Product Development and sustaining activities while managing product risk, cybersecurity, and design controls for medical devices.
  • Candidates must ensure Design Controls are compliant with IEC 62304 and drive risk management activities including SFMEA and Hazard Analyses.
  • Employees are eligible for a consolidated retirement plan, long-term incentives, and comprehensive time off benefits including parental leave.

Matching Summary

The role supports New Product Development and sustaining activities while managing product risk, cybersecurity, and design controls for medical devices.

Salary

Base: $92,000.00 - $148,350.00; Bonus/Equity: Long-term incentive program available; Benefits: 401(k), vacation, sick time, and parental leave

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or science
  • 2 years related work experience
  • IEC 62304 compliance knowledge
  • ISO 14971 risk management expertise
  • SaMD and SiMD technical systems

Nice-to-have

  • Agile and DevOps lifecycle experience
  • Cybersecurity threat analysis skills
  • JIRA and Confluence tool proficiency
  • Collaborative team environment fit
  • Self-motivated problem solving ability

Key Requirements

  • Minimum Bachelor's degree required
  • At least 2 years of relevant experience
  • Intermediate knowledge of 21 CFR Part 820
  • Experience with ISO 13485 and MDSAP

Work Rights

Not specified

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